Zhejiang Qizheng Pharmaceutical Co., Ltd

The test preparation was Ruxolitinib Phosphate Tablets (Specification: 20 mg) developed by Zhejiang Qizheng Pharmaceutical Co., Ltd., and the reference preparation was Ruxolitinib Phosphate Tablets (trade name: Jakavi, specification: 20 mg) licensed by Novartis Europharm Limited. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated after single administration in the fasting and postprandial states to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Entecavir tablets (specification: 0.5 mg) provided by Zhejiang Qizheng Pharmaceutical Co., Ltd. were used as the test preparation, and entecavir tablets (trade name: Boludin®, specification: 0.5 mg) produced by Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the fasting state were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Main purpose: Using imatinib mesylate tablets provided by Zhejiang Qizheng Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of imatinib mesylate tablets (trade name: Gleevec®, reference preparation) of the licensed manufacturer Novartis Pharma Schweiz AG were compared in healthy humans, and the human bioequivalence of the two preparations was investigated. Secondary purpose: To observe the safety of the test preparation imatinib mesylate tablets and the reference preparation imatinib mesylate tablets (Gleevec®) in healthy subjects.