TY - JOUR
T1 - A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects
T2 - an open label, three-way, three-period, partial replicate crossover study
AU - Paramanindita, Asti Swari
AU - Harahap, Yahdiana
AU - Prasaja, Budi
AU - Wijayanti, Tri Rahayu
AU - Lusthom, Windy
AU - Sofiah, Raden Efi
AU - Sandra, Monika
AU - Trisari, Yunia
N1 - Funding Information:
This study was supported by P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia.
Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - 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.
AB - 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.
KW - bioequivalence
KW - highly variable drug
KW - pharmacokinetics
KW - reference replicated
KW - Telmisartan
UR - http://www.scopus.com/inward/record.url?scp=85091887767&partnerID=8YFLogxK
U2 - 10.1080/03639045.2020.1820042
DO - 10.1080/03639045.2020.1820042
M3 - Article
C2 - 32892655
AN - SCOPUS:85091887767
SN - 0363-9045
VL - 46
SP - 1747
EP - 1752
JO - Drug Development and Industrial Pharmacy
JF - Drug Development and Industrial Pharmacy
IS - 11
ER -