Chengdu Jinhua Pharmaceutical Co Ltd.

Primary objective: This study investigates the pharmacokinetic characteristics of tadalafil tablets (test preparation, specification: 20 mg) produced by Chengdu Jinhua Pharmaceutical Co., Ltd. or tadalafil tablets (reference preparation, trade name: Cialis®, specification: 20 mg) produced by Lilly del Caribe, Inc., under fasting or postprandial conditions in healthy male subjects, compares their relative bioavailability, evaluates the bioequivalence between the two preparations, and provides a basis for the registration application of the test preparation. Secondary study objectives Observe the safety of single oral administration of the test preparation tadalafil tablets (specification: 20 mg) or the reference preparation tadalafil tablets (trade name: Cialis®, specification: 20 mg) in healthy Chinese male subjects under fasting and postprandial conditions.

The time course of blood drug concentration after a single oral dose of the test preparation, rifampicin capsules (0.15 g, produced by Chengdu Jinhua Pharmaceutical Co., Ltd.) was observed in healthy subjects in the fasting state, and the corresponding pharmacokinetic parameters were estimated. Rifampicin capsules (0.15 g, licensed by Sanofi-Aventis US LLC, trade name: RIFADIN) were used as the reference preparation for a formal bioequivalence trial, providing a reference for the consistency evaluation application and clinical application of the drug.

Main purpose: Using ethambutol hydrochloride tablets (trade name: Ebutol®, specification: 0.25g) produced by Kaken Pharmaceutical Co., Ltd. as the reference preparation and ethambutol hydrochloride tablets (specification: 0.25g) produced by Chengdu Jinhua Pharmaceutical Co., Ltd. as the test preparation, the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated through a single-center, randomized, open, two-period, double-crossover clinical trial design. Secondary purpose: Evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.