[Translation] A randomized, open-label, fasting single-dose, two-dose, two-sequence, two-cycle crossover and postprandial single-dose, two-drug, two-sequence, four-cycle study of tretinoin capsules in Chinese adult healthy subjects crossover bioequivalence studies
主要研究目的:
观察单次口服10mg(空腹/餐后)受试制剂维A酸胶囊(规格:10mg/粒,山东良福制药有限公司生产)与参比制剂维A酸胶囊(规格:10mg/粒,TEVA pharmaceuticals USA, INC.生产)在中国成年健康受试者体内的药代动力学特征,初步评估空腹与餐后状态下分别口服两种制剂的生物等效性及个体内变异度。次要研究目的:
观察受试制剂和参比制剂单次口服10mg(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
To observe a single oral administration of 10mg (fasting/after meal) test preparation tretinoin capsules (specification: 10mg/capsule, produced by Shandong Liangfu Pharmaceutical Co., Ltd.) and reference preparation tretinoin capsules (specification: 10mg/capsule, TEVA pharmaceuticals USA, INC. manufactures) pharmacokinetics in Chinese adult healthy subjects, and preliminarily evaluates the bioequivalence and intra-individual variability of the two oral preparations in fasting and postprandial states. Secondary research purposes:
To observe the safety of the test preparation and reference preparation at a single oral dose of 10 mg (fasting/after meals) in Chinese adult healthy subjects.