Bioequivalence Study of Two Formulations of Telmisartan 40 mg Tablets in Healthy Adult Bangladeshi Subjects under Fasting Conditions  

作　　者：Alimur Reza Sabrina Akter Tushi Nithon Chandra Sahana Uttom Kumar Bhowmik Abdullah Al Shafi Majumder Arifa Akram Alimur Reza;Sabrina Akter Tushi;Nithon Chandra Sahana;Uttom Kumar Bhowmik;Abdullah Al Shafi Majumder;Arifa Akram(Senior Manager, Beximco Pharmaceuticals Ltd., Paribag, Dhaka;Novus CRSL, Paribag, Dhaka;Department of Cardiology, Popular Medical College & Hospital, Dhanmondi, Dhaka;National Institute of Laboratory Medicine & Referral Centre (NILMRC) and Lab in Charge, Novus CRSL, Paribag, Dhaka)

机构地区：[1]Senior Manager, Beximco Pharmaceuticals Ltd., Paribag, Dhaka [2]Novus CRSL, Paribag, Dhaka [3]Department of Cardiology, Popular Medical College & Hospital, Dhanmondi, Dhaka [4]National Institute of Laboratory Medicine & Referral Centre (NILMRC) and Lab in Charge, Novus CRSL, Paribag, Dhaka

出　　处：《Advances in Bioscience and Biotechnology》2022年第9期419-427,共9页生命科学与技术进展（英文）

摘　　要：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_max. The 90% Confidence Interval for C_max, AUC_0-t & AUC_0-∞ 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^{^{^®}} 40 mg Tablet, under fasting conditions, a single dose of Telmisartan 40 mg Tablet is bioequivalent.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_max. The 90% Confidence Interval for C_max, AUC_0-t & AUC_0-∞ 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^{^{^®}} 40 mg Tablet, under fasting conditions, a single dose of Telmisartan 40 mg Tablet is bioequivalent.

关 键 词：BIOEQUIVALENCE TELMISARTAN Micardis Pharmacokinetics 

分 类 号：R96[医药卫生—药理学]