Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence...Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (C<sub>max</sub>), the area under the plasma concentration-time curve from time zero to time t (AUC<sub>0–t</sub>), and AUC from t = 0 to infinity (AUC<sub>0–∞</sub>). The other PK parameters included time to reach C<sub>max</sub> (T<sub>max</sub>), terminal elimination rate constant (K<sub>el</sub>), and half-life (t<sub>1/2</sub>). Result: The ratios and 90% CI for the geometric mean test/reference were 95.53% (86.70% - 105.26%) for C<sub>max</sub>, 101.75% (95.42% - 108.49%) for AUC<sub>0</sub><sub>−</sub><sub>t</sub>, and 101.54% (95.59%% - 107.87%) for AUC<sub>0</sub><sub>−</sub><sub>∞</sub>. The formulations were bioequivalent since the 90% CIs for the geometric mean test/reference ratios were 80% to 125%, according to the predetermined range of US Food and Drug Administration (FDA) requirements. Conclusion: This single-dose investigation shows that the Dienogest test and reference formulations exhibited a rate and degree of absorption that met the regulatory requirements for bioequivalence.展开更多
Background: Vonoprazan fumarate, a novel potassium-competitive acid blocker, outperforms traditional proton pump inhibitors in acid suppression and can be effectively combined with antibiotics to eradicate Helicobacte...Background: Vonoprazan fumarate, a novel potassium-competitive acid blocker, outperforms traditional proton pump inhibitors in acid suppression and can be effectively combined with antibiotics to eradicate Helicobacter pylori. Objective: The study aimed to determine if two Vonoprazan formulations—Vonoprazan Fumarate 20 mg Tablet of Beximco Pharmaceuticals Limited, Bangladesh (test product) and Takecab 20 mg Tablet of Takeda Pharmaceutical Company Limited, Japan (reference product)—met FDA’s bioequivalence requirements by comparing their pharmacokinetic characteristics in healthy Bangladeshi adults. Methods: This was a single-center, randomized, open-label, two-period, two-sequence, laboratory-blind, double-crossover experiment. After 10 hours of fasting, 18 subjects were randomly assigned to receive a single oral dose of either formulation. During each treatment period, blood samples were collected at specific times (pre-dose and up to 48 hours post-dose) to measure plasma Vonoprazan levels using liquid chromatography-tandem mass spectrometry. A non-compartmental model was used to calculate pharmacokinetic parameters using the plasma drug concentration-time profile. A statistical comparison of the pharmacokinetic parameters of the two formulations of the test and reference product was conducted using SAS® statistical software to assess the bioequivalence. Primary pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) and secondary parameters (Tmax, T1/2, Kel, and AUC extrapolation) were calculated for both drug formulations. If the confidence intervals for the natural log-transformed Cmax, AUC0-t, and AUC0-∞ values fell between 80% and 125%, the drug products would be considered bioequivalent. Result: The geometric mean ratio of Vonoprazan between the test and reference groups was found to be 109.04% (99.47% - 119.53%), 101.37% (95.58% - 107.50%), and 101.24% (95.43% - 107.41%), with 90% confidence intervals (CIs) for the Cmax, AUC0–t, and AUC0–∞, and these outcomes met the regulatory requirements for assuming bioequivalence. Conclusion: The results demonstrated that the generic formulation of Vonoprazan 20 mg Tablet of Beximco Pharmaceuticals Limited is bioequivalent to the reference product.展开更多
With the COVID-19 pandemic, disparities between the infection rate and death rate in different countries become a major concern. In some countries, lower mortality rate compared to others can be explained by better te...With the COVID-19 pandemic, disparities between the infection rate and death rate in different countries become a major concern. In some countries, lower mortality rate compared to others can be explained by better testing capacity and intensive care facilities. Complete SARS-CoV-2 genome sequences from different countries of the world are continually submitted to Global Initiative for Sharing All Influenza Data using Next Generation Sequencing method. A SARS-CoV-2 variant with a D 614G Mutation in the spike (S) protein has become the most dominant form in the global pandemic. There are a number of ongoing studies trying to relate this mutation with the infectivity, mortality, transmissibility of the virus and its impact on vaccine development. This review aims to accumulate the major findings from some of these studies and focus its future implication. Some studies suggested D 614G strain has increased binding capacity, it affects more cells at a faster rate, so has a high transmissibility. Patients infected with this strain were found with high viral load. But still now there is no such evidence that this strain produces more severe disease as well as increased mortality. The structural change of spike protein produced by D 614G mutation was minor and did not hamper the vaccine efficacy. Some studies showed antibodies produced against D614 strain can neutralize G614 strain and <em>vice versa</em>. Whenever a mutation occurs in spike protein there are always chances of affecting the infectivity, transmissibility, vaccine efficacy. Therefore, more studies are required to find out the overall effect of D 614G mutation.展开更多
<b><span style="font-family:Verdana;">Background</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana...<b><span style="font-family:Verdana;">Background</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:Verdana;"> Since 2019, the pandemic of Coronavirus disease 2019</span><span style="font-family:Verdana;"> (COVID-</span><span style="font-family:Verdana;">19) has spread very rapidly in China and Worldwide. COVID-19 is a highly contagious, infectious and rapidly spreading viral disease with an alarming case fatality rate up to 5%. </span><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Case</span></b><span style="font-family:Verdana;"></span><b><span style="font-family:;" "=""> </span></b><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Report</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:;" "=""><span style="font-family:Verdana;"> In this article, we report a case of 60 years old non diabetic, hypertensive woman infected with COVID-19 who </span><span style="font-family:Verdana;">has end stage renal disease (ESRD) on hemodialysis for last 18 months.</span></span><span style="font-family:;" "=""> </span><span style="font-family:Verdana;">COVID-</span><span style="font-family:;" "=""><span style="font-family:Verdana;">19 patients with ESRD need isolation dialysis but most of them cannot be handled properly due to limited hemodialysis machine. With these unavailability and risk, we continue the treatment along with hemodialysis for controlling uraemia and fluid balance. With all effort this patient ended with an uneventful course with clinical improvement, improvement of all laboratory </span><span style="font-family:Verdana;">parameters and resolution of radiological findings but follow up RT-PCR</span><span style="font-family:Verdana;"> cannot done due to changing guideline of discharge criteria of COVID-19 patient in Bangladesh.</span></span><span style="font-family:;" "=""> </span><span style="font-family:Verdana;">He positively responded to meropenem, clarithromycin, favi</span><span style="font-family:Verdana;">piravir, thromboprophylaxis with enoxaparin along with supplemental oxygen therapy. After that she was discharged with an advice of 14 days home isolation with regular hemodialysis and a follow up visit after 14 days in the outpatient department. </span><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Conclusion</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:;" "=""> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">An ESRD patient on regular hemodialysis suffering from severe pneumonia has high risk of mortality. Combined </span><span style="font-family:Verdana;">effort from the health care workers are needed to decrease the mortality of</span><span style="font-family:Verdana;"> COVID-19 infected ESRD patients.</span></span>展开更多
Background: Telmisartan is a highly variable drug which is used to treat hypertension. This study compared to compare the bioavailability of two 40 mg Telmisartan tablets in adult and healthy Bangladeshi subjects. Mat...Background: Telmisartan is a highly variable drug which is used to treat hypertension. This study compared to compare the bioavailability of two 40 mg Telmisartan tablets in adult and healthy Bangladeshi subjects. Materials and Method: This study was open label, randomized, laboratory blind, single dose, three periods, two treatments, three-sequence, partial-replicate, crossover and comparative oral bioavailability study. In this study, 18 Bangladeshi subjects were enrolled and 17 subjects were completed. Serial blood samples were collected up to 96 hours following drug administration. By using Liquid Chromatography Mass Spectrometry (LC-MS/MS) method, plasma concentrations of Telmisartan were determined. Results: The two formulations of Telmisartan were considered bioequivalent if 90% Confidence Interval (CI) fall within the range of 80.00% - 125.00% for AUC parameters and reference-scaled-average bioequivalence of 69.84% - 143.19% for C<sub>max</sub>. The 90% Confidence Interval for C<sub>max</sub>, AUC<sub>0-t</sub> & AUC<sub>0-∞</sub> was found 84.88% - 107.79%, 89.76% - 109.55%, and 91.20% - 114.52%, respectively. Conclusion: According to rate and extent of absorption with the single dose of Reference Product (R): Micardis<sup><sup><sup>®</sup></sup></sup> 40 mg Tablet, under fasting conditions, a single dose of Telmisartan 40 mg Tablet is bioequivalent.展开更多
文摘Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (C<sub>max</sub>), the area under the plasma concentration-time curve from time zero to time t (AUC<sub>0–t</sub>), and AUC from t = 0 to infinity (AUC<sub>0–∞</sub>). The other PK parameters included time to reach C<sub>max</sub> (T<sub>max</sub>), terminal elimination rate constant (K<sub>el</sub>), and half-life (t<sub>1/2</sub>). Result: The ratios and 90% CI for the geometric mean test/reference were 95.53% (86.70% - 105.26%) for C<sub>max</sub>, 101.75% (95.42% - 108.49%) for AUC<sub>0</sub><sub>−</sub><sub>t</sub>, and 101.54% (95.59%% - 107.87%) for AUC<sub>0</sub><sub>−</sub><sub>∞</sub>. The formulations were bioequivalent since the 90% CIs for the geometric mean test/reference ratios were 80% to 125%, according to the predetermined range of US Food and Drug Administration (FDA) requirements. Conclusion: This single-dose investigation shows that the Dienogest test and reference formulations exhibited a rate and degree of absorption that met the regulatory requirements for bioequivalence.
文摘Background: Vonoprazan fumarate, a novel potassium-competitive acid blocker, outperforms traditional proton pump inhibitors in acid suppression and can be effectively combined with antibiotics to eradicate Helicobacter pylori. Objective: The study aimed to determine if two Vonoprazan formulations—Vonoprazan Fumarate 20 mg Tablet of Beximco Pharmaceuticals Limited, Bangladesh (test product) and Takecab 20 mg Tablet of Takeda Pharmaceutical Company Limited, Japan (reference product)—met FDA’s bioequivalence requirements by comparing their pharmacokinetic characteristics in healthy Bangladeshi adults. Methods: This was a single-center, randomized, open-label, two-period, two-sequence, laboratory-blind, double-crossover experiment. After 10 hours of fasting, 18 subjects were randomly assigned to receive a single oral dose of either formulation. During each treatment period, blood samples were collected at specific times (pre-dose and up to 48 hours post-dose) to measure plasma Vonoprazan levels using liquid chromatography-tandem mass spectrometry. A non-compartmental model was used to calculate pharmacokinetic parameters using the plasma drug concentration-time profile. A statistical comparison of the pharmacokinetic parameters of the two formulations of the test and reference product was conducted using SAS® statistical software to assess the bioequivalence. Primary pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) and secondary parameters (Tmax, T1/2, Kel, and AUC extrapolation) were calculated for both drug formulations. If the confidence intervals for the natural log-transformed Cmax, AUC0-t, and AUC0-∞ values fell between 80% and 125%, the drug products would be considered bioequivalent. Result: The geometric mean ratio of Vonoprazan between the test and reference groups was found to be 109.04% (99.47% - 119.53%), 101.37% (95.58% - 107.50%), and 101.24% (95.43% - 107.41%), with 90% confidence intervals (CIs) for the Cmax, AUC0–t, and AUC0–∞, and these outcomes met the regulatory requirements for assuming bioequivalence. Conclusion: The results demonstrated that the generic formulation of Vonoprazan 20 mg Tablet of Beximco Pharmaceuticals Limited is bioequivalent to the reference product.
文摘With the COVID-19 pandemic, disparities between the infection rate and death rate in different countries become a major concern. In some countries, lower mortality rate compared to others can be explained by better testing capacity and intensive care facilities. Complete SARS-CoV-2 genome sequences from different countries of the world are continually submitted to Global Initiative for Sharing All Influenza Data using Next Generation Sequencing method. A SARS-CoV-2 variant with a D 614G Mutation in the spike (S) protein has become the most dominant form in the global pandemic. There are a number of ongoing studies trying to relate this mutation with the infectivity, mortality, transmissibility of the virus and its impact on vaccine development. This review aims to accumulate the major findings from some of these studies and focus its future implication. Some studies suggested D 614G strain has increased binding capacity, it affects more cells at a faster rate, so has a high transmissibility. Patients infected with this strain were found with high viral load. But still now there is no such evidence that this strain produces more severe disease as well as increased mortality. The structural change of spike protein produced by D 614G mutation was minor and did not hamper the vaccine efficacy. Some studies showed antibodies produced against D614 strain can neutralize G614 strain and <em>vice versa</em>. Whenever a mutation occurs in spike protein there are always chances of affecting the infectivity, transmissibility, vaccine efficacy. Therefore, more studies are required to find out the overall effect of D 614G mutation.
文摘<b><span style="font-family:Verdana;">Background</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:Verdana;"> Since 2019, the pandemic of Coronavirus disease 2019</span><span style="font-family:Verdana;"> (COVID-</span><span style="font-family:Verdana;">19) has spread very rapidly in China and Worldwide. COVID-19 is a highly contagious, infectious and rapidly spreading viral disease with an alarming case fatality rate up to 5%. </span><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Case</span></b><span style="font-family:Verdana;"></span><b><span style="font-family:;" "=""> </span></b><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Report</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:;" "=""><span style="font-family:Verdana;"> In this article, we report a case of 60 years old non diabetic, hypertensive woman infected with COVID-19 who </span><span style="font-family:Verdana;">has end stage renal disease (ESRD) on hemodialysis for last 18 months.</span></span><span style="font-family:;" "=""> </span><span style="font-family:Verdana;">COVID-</span><span style="font-family:;" "=""><span style="font-family:Verdana;">19 patients with ESRD need isolation dialysis but most of them cannot be handled properly due to limited hemodialysis machine. With these unavailability and risk, we continue the treatment along with hemodialysis for controlling uraemia and fluid balance. With all effort this patient ended with an uneventful course with clinical improvement, improvement of all laboratory </span><span style="font-family:Verdana;">parameters and resolution of radiological findings but follow up RT-PCR</span><span style="font-family:Verdana;"> cannot done due to changing guideline of discharge criteria of COVID-19 patient in Bangladesh.</span></span><span style="font-family:;" "=""> </span><span style="font-family:Verdana;">He positively responded to meropenem, clarithromycin, favi</span><span style="font-family:Verdana;">piravir, thromboprophylaxis with enoxaparin along with supplemental oxygen therapy. After that she was discharged with an advice of 14 days home isolation with regular hemodialysis and a follow up visit after 14 days in the outpatient department. </span><span style="font-family:Verdana;"></span><b><span style="font-family:Verdana;">Conclusion</span></b><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"></span><span style="font-family:;" "=""> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">An ESRD patient on regular hemodialysis suffering from severe pneumonia has high risk of mortality. Combined </span><span style="font-family:Verdana;">effort from the health care workers are needed to decrease the mortality of</span><span style="font-family:Verdana;"> COVID-19 infected ESRD patients.</span></span>
文摘Background: Telmisartan is a highly variable drug which is used to treat hypertension. This study compared to compare the bioavailability of two 40 mg Telmisartan tablets in adult and healthy Bangladeshi subjects. Materials and Method: This study was open label, randomized, laboratory blind, single dose, three periods, two treatments, three-sequence, partial-replicate, crossover and comparative oral bioavailability study. In this study, 18 Bangladeshi subjects were enrolled and 17 subjects were completed. Serial blood samples were collected up to 96 hours following drug administration. By using Liquid Chromatography Mass Spectrometry (LC-MS/MS) method, plasma concentrations of Telmisartan were determined. Results: The two formulations of Telmisartan were considered bioequivalent if 90% Confidence Interval (CI) fall within the range of 80.00% - 125.00% for AUC parameters and reference-scaled-average bioequivalence of 69.84% - 143.19% for C<sub>max</sub>. The 90% Confidence Interval for C<sub>max</sub>, AUC<sub>0-t</sub> & AUC<sub>0-∞</sub> was found 84.88% - 107.79%, 89.76% - 109.55%, and 91.20% - 114.52%, respectively. Conclusion: According to rate and extent of absorption with the single dose of Reference Product (R): Micardis<sup><sup><sup>®</sup></sup></sup> 40 mg Tablet, under fasting conditions, a single dose of Telmisartan 40 mg Tablet is bioequivalent.
