Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.

Primary Objective: To conduct a comparative pharmacokinetics study of the test formulation, leuprorelin acetate microspheres for injection (11.25 mg, in-house developed), and the reference formulation, leuprorelin acetate microspheres for injection (trade name: ENANTONE, 11.25 mg, owned by Takeda Pharmaceutical Company Limited), in postmenopausal women. The pharmacokinetic similarity of the two formulations following a single dose under fasting conditions was compared. Secondary Objective: To evaluate the safety of a single injection of the test formulation (leuprorelin acetate microspheres for injection, T) and the reference formulation (ENANTONE, R) in postmenopausal women.

Primary Objective: A bioequivalence study was conducted using diclofenac diethylamine emulsion (1% (20g:0.2g, calculated as C₁₄H₁₃Cl₂NNaO₂)) produced by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd. as the test formulation and diclofenac diethylamine emulsion (trade name: Voltaren®, 1% (20g:0.2g, calculated as C₁₄H₁₃Cl₂NNaO₂)) produced by Haleon Schweiz AG as the reference formulation. The bioequivalence of the two formulations was compared after a single dose under fasting conditions. Secondary Objective: To evaluate the safety of a single dose of the test formulation (diclofenac diethylamine emulsion, T) and the reference formulation (Voltaren®, R) in healthy adult study participants from China.