Bioequivalence of tadalafil tablets in healthy male subjects

Author: Xiaomin LI ¹ ; Yanxin ZHANG ¹ ; Sumei XU ¹ ; Xiaolei HU ¹ ; Pingsheng XU ¹ ; Zhiheng YI ² ; Lin PAN ²
Author Information

1. Phase I Clinical Research Unit, Xiangya Hospital, Central South University
2. Hunan Dinuo Pharmaceutical Co., Ltd.
Publication Type:Journal Article
Keywords: Bioequivalence; LC-MS/MS; Pharmacokinetics; Tadalafil tablets
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(11):1279-1284
CountryChina
Language:Chinese
Abstract: AIM: To study the bioequivalence of two tadalafil tablets in Chinese healthy male subjects. METHODS: A randomized, open-label, two-period, two-sequence, crossover study designing was adopted in the study. Thirty-six healthy male subjects were enrolled under fasting condition and fed condition, respectively. Each subject was given a single oral dose of tadalafil tablet (20 mg). The concentration of tadalafil in plasma was determined by LC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin 8.0 program, and statistical analysis was performed by using SAS 9.4 statistics software. RESULTS: Under fasting condition, the pharmacokinetic parameters of tadalafil of the test (T) and reference (R) preparation were as follows: C