Yunpeng Pharmaceutical Group Co Ltd.

Primary objective: To evaluate the bioequivalence of tamsulosin hydrochloride extended-release capsules (0.2 mg) manufactured by Yunpeng Pharmaceutical Group Co., Ltd., and tamsulosin hydrochloride extended-release capsules (trade name: Harle®; 0.2 mg) manufactured by Astellas Pharma (China) Co., Ltd., in a healthy Chinese male population after single oral administration, both fasting and after a meal. Secondary objective: To evaluate the safety of the test formulation and the reference formulation in healthy adult male participants in China.

Primary Study Objective: In accordance with relevant bioequivalence testing regulations, we selected Rexulti® OD Tablets (2 mg), manufactured by Otsuka Pharmaceutical Co., Ltd., as the reference formulation, to conduct a human bioequivalence study on the test formulation, Rexulti® OD Tablets (2 mg), manufactured and supplied by Yunpeng Pharmaceutical Group Co., Ltd., under both fasting and postprandial administration conditions. We compared the absorption rate and extent of absorption of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, and evaluated the bioequivalence of the two formulations under fasting and postprandial administration conditions. Secondary Study Objective: To observe the safety of oral administration of the test formulation Rexulti® OD Tablets (2 mg) and the reference formulation Rexulti® OD Tablets (2 mg) in healthy subjects.

Primary objective: In accordance with relevant bioequivalence testing regulations, cimetidine tablets (trade name: TAGAMET HB, strength: 0.2g), manufactured by MEDTECH PRODUCTS INC., was selected as the reference formulation. A fasting-administered human bioequivalence study was conducted on the test formulation cimetidine tablets (strength: 0.2g) manufactured and supplied by Yunpeng Pharmaceutical Group Co., Ltd. The study compared the absorption rate and extent of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, and evaluated the bioequivalence of the two formulations under fasting administration conditions. Secondary objective: To observe the safety of oral administration of the test formulation cimetidine tablets (strength: 0.2g) and the reference formulation cimetidine tablets (trade name: TAGAMET HB, strength: 0.2g) to healthy participants.