/ Not yet recruitingNot Applicable 盐酸克林霉素棕榈酸酯颗粒在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of clindamycin palmitate hydrochloride granules in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下，古戈尔药业（海南）有限责任公司提供的盐酸克林霉素棕榈酸酯颗粒（1.5g(75mg/5mL)(按C18H33ClN2O5S计)）与Pfizer INC持证的盐酸克林霉素棕榈酸酯颗粒（75mg/5mL(以克林霉素计)，商品名：Cleocin®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。
次要目的
评价空腹和餐后给药条件下，古戈尔药业（海南）有限责任公司提供的盐酸克林霉素棕榈酸酯颗粒（1.5g(75mg/5mL)(按C18H33ClN2O5S计)）与Pfizer INC持证的盐酸克林霉素棕榈酸酯颗粒（75mg/5mL(以克林霉素计)，商品名：Cleocin®）在健康成年人群中的安全性。
[Translation] Main purpose
To compare the differences in absorption extent and rate of clindamycin palmitate granules (1.5g (75mg/5mL) (calculated as C18H33ClN2O5S)) provided by Guger Pharmaceuticals (Hainan) Co., Ltd. and clindamycin palmitate granules (75mg/5mL (calculated as clindamycin), trade name: Cleocin®) certified by Pfizer INC in healthy adults under fasting and fed administration conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of clindamycin palmitate granules (1.5g (75mg/5mL) (calculated as C18H33ClN2O5S)) provided by Guger Pharmaceuticals (Hainan) Co., Ltd. and clindamycin palmitate granules (75mg/5mL (calculated as clindamycin), trade name: Cleocin®) certified by Pfizer INC in healthy adults under fasting and fed administration conditions.
/ CompletedNot Applicable 中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state
主要研究目的
研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，浙江赛默制药有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。
次要研究目的
评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Duphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Duphaston®) after a single oral administration in healthy Chinese female subjects after fasting and feeding.
100 Clinical Results associated with Gugel Pharmaceutical (Hainan) Co., Ltd.
0 Patents (Medical) associated with Gugel Pharmaceutical (Hainan) Co., Ltd.
100 Deals associated with Gugel Pharmaceutical (Hainan) Co., Ltd.
100 Translational Medicine associated with Gugel Pharmaceutical (Hainan) Co., Ltd.
