Key result
A single dose of the test telmisartan formulation was bioequivalent to the reference product under fasting conditions, with the 90% CI for Cmax falling within the 80-125% acceptance range.
Why the study?
Telmisartan is a highly variable drug used to treat hypertension, and this study was conducted to compare the bioavailability of two 40 mg telmisartan tablets in healthy adult Bangladeshi subjects.
Is a generic formulation of Telmisartan 40 mg bioequivalent to the reference product (Micardis) in healthy adult Bangladeshi subjects?
RCT (n=18)
Open-label, laboratory blind
Randomized (three-sequence, partial-replicate, crossover)
No
Is a generic formulation of Telmisartan 40 mg bioequivalent to the reference product (Micardis) in healthy adult Bangladeshi subjects?
A generic formulation of Telmisartan 40 mg is bioequivalent to the reference product Micardis in healthy Bangladeshi adults under fasting conditions.
Answers are grounded in this paper and cite their sources.
May support generic telmisartan substitution; leaves open fed-state and outcome data needs.
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.
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Reza et al. (2022) conducted an RCT in Healthy (n=18). Telmisartan vs. Micardis 40 mg was evaluated on Bioequivalence (Cmax) (T/R ratio 95.65%, 95% CI 84.88-107.79). A single dose of the test telmisartan formulation was bioequivalent to the reference product under fasting conditions, with the 90% CI for Cmax falling within the 80-125% acceptance range.
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