Bioequivalence and Food Effect Assessment of Two Fixed‐Dose Combination Formulations of Telmisartan‐Hydrochlorothiazide Tablets in Chinese Healthy Subjects

• Published in: Clinical and translational science Vol. 18; no. 5; pp. e70228 - n/a
• Main Authors: Hu, Minwan, Yang, Man, Zhang, Shuyu, Li, Jiangfan, Pang, Hongxian, Pei, Yingzi, Guo, Chao, Wang, Xuhong
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.05.2025; John Wiley and Sons Inc; Wiley
• Subjects: Administration, Oral; Adult; Antihypertensives; Area Under Curve; Asian People; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Benzimidazoles - pharmacokinetics; Benzoates - administration & dosage; Benzoates - pharmacokinetics; Bioequivalence; Blood pressure; China; Clinical trials; Cross-Over Studies; Disease; Drug Combinations; Drug dosages; East Asian People; Enzymes; Fasting; FDA approval; Female; fixed‐dose combination (FDC); Food-Drug Interactions; Generic drugs; Healthy Volunteers; Hepatitis; Humans; Hydrochlorothiazide; Hydrochlorothiazide - administration & dosage; Hydrochlorothiazide - adverse effects; Hydrochlorothiazide - pharmacokinetics; Hypertension; Integrity Check; Male; Metabolism; Middle Aged; Patients; Pharmaceuticals; Pharmacokinetics; Plasma; Regulatory approval; Tablets; Tandem Mass Spectrometry; telmisartan; Telmisartan - administration & dosage; Telmisartan - adverse effects; Telmisartan - pharmacokinetics; Therapeutic Equivalency; Young Adult; China; Beijing China; pharmacokinetics; fixed‐dose combination (FDC); telmisartan; bioequivalence; hydrochlorothiazide

ABSTRACT This study assessed the bioequivalence and food effect of two fixed‐dose combination (FDC) formulations of telmisartan‐hydrochlorothiazide tablets (telmisartan 40 mg, hydrochlorothiazide 12.5 mg) in healthy Chinese subjects. Seventy‐two subjects were enrolled and divided into fasted and fed...