Shanxi Xingbang Pharmaceutical Co. Ltd.

Through the bioequivalence test of the two preparations, namely the lamivudine tablets generically manufactured by Shaanxi Xingbang Pharmaceutical Co., Ltd. and the lamivudine tablets manufactured by GlaxoSmithKline, a basis is provided for Shaanxi Xingbang Pharmaceutical Co., Ltd. to apply for registration of lamivudine tablets, and a reference is provided for the production and rational clinical use of this product.

According to the relevant provisions of bioequivalence test, calcium dobesilate capsules (trade name: Doxium®, specification: 0.5g/capsule) produced by Ebewe Pharma Ges.m.b.H.Nfg.KG were selected as the reference preparation. The human bioequivalence test of calcium dobesilate capsules produced by Shaanxi Xingbang Pharmaceutical Co., Ltd. was carried out on the fasting and fed administration. The differences in the absorption degree and absorption rate of the drug in the test preparation and the reference preparation were compared to see whether they were within an acceptable range, and the bioequivalence of the two preparations under the conditions of fasting and fed administration was compared.

To explore the clinical efficacy and safety of Sanxiang Ruzengxiao Capsule in the treatment of fibrocystic fibrosis (liver depression and phlegm stagnation syndrome), and to compare it with similar products that are clinically recognized, safe and effective, to determine the clinical value and provide a basis for Phase III clinical research.