TITLE:
Bioequivalence Study of Two Formulations of Telmisartan 40 mg Tablets in Healthy Adult Bangladeshi Subjects under Fasting Conditions
AUTHORS:
Alimur Reza, Sabrina Akter Tushi, Nithon Chandra Sahana, Uttom Kumar Bhowmik, Abdullah Al Shafi Majumder, Arifa Akram
KEYWORDS:
Bioequivalence, Telmisartan, Micardis, Pharmacokinetics
JOURNAL NAME:
Advances in Bioscience and Biotechnology,
Vol.13 No.9,
September
22,
2022
ABSTRACT: 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 Cmax.
The 90% Confidence Interval for Cmax, AUC0-t & AUC0-∞ 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.