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

Asti Swari Paramanindita, Yahdiana Harahap, Budi Prasaja, Tri Rahayu Wijayanti, Windy Lusthom, Raden Efi Sofiah, Monika Sandra, Yunia Trisari

Research output: Contribution to journalArticlepeer-review

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 AUC0–t, AUC0–∞, 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 AUC0–t, AUC0–∞, 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.

Original languageEnglish
JournalDrug Development and Industrial Pharmacy
DOIs
Publication statusAccepted/In press - 2020

Keywords

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

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