Bioequivalence Study of Tadalafil Oral Soluble Film and Tadalafil Tablet in Healthy Chinese Volunteers Under Fasting Conditions.

ABSTRACT: To investigate if a newly developed tadalafil oral soluble film (OSF) was bioequivalent to the approved tadalafil tablets, a clinical study was conducted in healthy Chinese male volunteers under fasting conditions. In this study, 36 volunteers were randomized into three groups and received one tadalafil tablet, one tadalafil OSF with water, or one OSF without water in each period. The dosages were all 10 mg. Blood samples were collected and centrifuged. Plasma concentrations of tadalafil were determined by liquid chromatography tandem mass spectrometry. Pharmacokinetic (PK) parameters including maximum plasma concentration (C_max), area under the concentration versus time curve (AUC) from dosing to the last sampling time (AUC_0-t), AUC from administration to infinity (A

SUBMITTER: Jiang X 

PROVIDER: S-EPMC12675823 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature