Zhongshan Bailing Biotechnology Co., Ltd.

A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation ursodeoxycholic acid tablets (strength: 50 mg) and the reference preparation ursodeoxycholic acid tablets (URSO®, strength: 50 mg) in healthy adult subjects under fasting and fed conditions.

①Main purpose: To evaluate the relative bioavailability and bioequivalence of the test preparation and the reference preparation under fasting/postprandial conditions through a randomized, open, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study with pharmacokinetic parameters as the endpoint evaluation indicators. ②Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.