Jilin Boda Pharmaceutical Co., Ltd.

To study the in vivo pharmacokinetics of the test preparation rivaroxaban tablets (Jilin Boda Pharmaceutical Co., Ltd., specification: 15 mg) and the reference preparation rivaroxaban tablets (trade name: Xarelto®; Bayer AG, specification: 15 mg) in healthy subjects after a single oral administration in the fasting and postprandial states, to evaluate the bioequivalence of the test preparation and the reference preparation, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Healthy adult subjects were orally administered a single dose of the test preparation and the reference preparation of rivaroxaban tablets on an empty stomach and after a meal, respectively. The pharmacokinetic parameters were used as the endpoint evaluation indicators. According to the relevant provisions of the bioequivalence study, the bioequivalence of rivaroxaban tablets (test preparation) produced by Jilin Boda Pharmaceutical Co., Ltd. and rivaroxaban tablets (reference preparation, trade name: Xarelto®) produced by Bayer HealthCare Co., Ltd. was evaluated.

The bioequivalence of levetiracetam injection and levetiracetam tablets was evaluated by having healthy subjects receive a single intravenous infusion of levetiracetam injection and a single oral dose of levetiracetam tablets, respectively.