Xian Detian Pharmaceutical Co. Ltd.

Venlafaxine hydrochloride sustained-release capsules (EFEXOR®XR, 75 mg/capsule) produced by Pfizer Healthcare Irelands were used as the reference preparation, and venlafaxine hydrochloride sustained-release capsules (75 mg/capsule) developed by Xi'an Yuanda Detian Pharmaceutical Co., Ltd. were used as the test preparation. The pharmacokinetic characteristics of the two preparations were compared through a single-center, randomized, open, two-period, double-crossover trial design, and the bioequivalence of the two preparations under postprandial administration conditions was evaluated.

Primary objective: Using lamotrigine dispersible tablets (25mg, trade name: Lamictal) produced by GlaxoSmithKline Pharmaceuticals S.A. and licensed by The Wellcome Foundation Ltd. as the reference preparation, and lamotrigine dispersible tablets (25mg) produced by Xi'an Yuanda Detian Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-period, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and fed states in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Nimodipine injection (II) provided by Shenyang Dongxing Pharmaceutical Technology Co., Ltd. was used as the test preparation, and a single dose was conducted with nimodipine injection (reference preparation, trade name: Nimodipine®) produced by Bayer Pharma AG. , a comparative bioavailability test of 12 hours of continuous intravenous infusion (containing 11 mg of nimodipine). At the same time, the safety of the test preparation and the reference preparation (containing nimodipine 11 mg) was observed in healthy subjects after a single dose and continuous 12-hour intravenous infusion.