A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects: an open label, three-way, three-period, partial replicate crossover study. (1st November 2020)

• Record Type: Journal Article
• Authors: Paramanindita, Asti Swari; Harahap, Yahdiana; Prasaja, Budi; Wijayanti, Tri Rahayu; Lusthom, Windy; Sofiah, Raden Efi; Sandra, Monika; Trisari, Yunia
• Is Part Of: Drug development and industrial pharmacy. Volume 46:Number 11(2020)
• Page Start: 1747
• Page End: 1752
• Publication Date: 2020-11-01
• Subjects: Telmisartan -- highly variable drug -- reference replicated -- bioequivalence -- pharmacokinetics; Pharmaceutical chemistry -- Periodicals; Pharmaceutical industry -- Periodicals; Drug Industry -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615.05
• DOI: 10.1080/03639045.2020.1820042
• Languages: English
• ISSNs: 0363-9045

Abstract

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.