Shenyang Wosen Institute Of Pharmacy

To study the pharmacokinetics of leuprolide acetate injection in healthy humans, explore the characteristics of drug absorption, distribution, metabolism and excretion in the human body, and clarify its pharmacokinetic characteristics, so as to provide a definite experimental basis for the design of clinical dosing regimen and dosage determination of leuprolide acetate injection, and provide a theoretical basis for the dosing regimen of Phase II clinical trials.

To evaluate the efficacy and safety of domestic leuprolide acetate immediate-release injection and leuprolide acetate sustained-release injection in the treatment of prostate cancer.

Primary study objective: To conduct a preliminary bioequivalence study under fasting and fed conditions using prasugrel hydrochloride tablets as the test preparation T and EFFIENT® produced by Eli Lilly and Co as the reference preparation R. Secondary study objective: To evaluate the safety of prasugrel hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions.