Bioequivalence Study of Two Formulations of Telmisartan 40 mg Tablets in Healthy Adult Bangladeshi Subjects under Fasting Conditions
- 1 Senior Manager, Beximco Pharmaceuticals Ltd., Paribag, Dhaka
- 2 Novus CRSL, Paribag, Dhaka
- 3 Novus CRSL, Paribag, Dhaka
- 4 Novus CRSL, Paribag, Dhaka
- 5 Department of Cardiology, Popular Medical College & Hospital, Dhanmondi, Dhaka
- 6 National Institute of Laboratory Medicine & Referral Centre (NILMRC) and Lab in Charge, Novus CRSL, Paribag, Dhaka
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 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 <sup>®</sup> 40 mg Tablet, under fasting conditions, a single dose of Telmisartan 40 mg Tablet is bioequivalent.
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