A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects: an open label, three-way, three-period, partial replicate crossover study

Abstract

Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period. In this study, 31 Indonesian subjects were enrolled and 28 subjects were completed the study. Serial blood samples were collected up to 72 h following drug administration. Plasma concentrations of telmisartan were determined using high-performance liquid chromatography method with fluorescence detector. The pharmacokinetic parameters of AUC_0–t, AUC_0–∞, and C_max were assessed for bioequivalence. Bioequivalence acceptance was based on predefined criteria of 90% confidence interval (CI) of 80.00–125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73–139.42% for C_max. The 90% CI for AUC_0–t, AUC_0–∞, and C_max was 96.11–107.25%, 93.06–104.36%, and 94.23–127.01%, respectively. These results indicated that the two formulations of telmisartan were bioequivalent.

Keywords:

• Telmisartan
• highly variable drug
• reference replicated
• bioequivalence
• pharmacokinetics

Disclosure statement

Asti Swari Paramanindita, Budi Prasaja, Tri Rahayu Wijayanti, Windy Lusthom, Raden Efi Sofiah, Monika Sandra are employees of the contract organization P.T. Clinisindo Laboratories, Jakarta, Indonesia.

Additional information

Funding

This study was supported by P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia.