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-cycle repeated crossover design bioequivalence trial of oral dydrogesterone tablets in Chinese healthy female subjects under fasting and postprandial conditions
主要目的:
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,苏州朗科生物技术股份有限公司)与参比制剂地屈孕酮片(商品名:达芙通®,规格:10mg,Abbott Healthcare Products B.V.)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 purpose:
Study the single oral administration of the test preparation dydrogesterone tablets (specification: 10 mg, Suzhou Langke Biotechnology Co., Ltd.) and the reference preparation dydrogesterone tablets (trade name: Diphton®, specifications) in the fasting and postprandial state : 10 mg, Abbott Healthcare Products B.V.) in healthy Chinese female subjects, to evaluate the bioequivalence of the two preparations.
Secondary purpose:
To evaluate the safety of test preparation (T) dydrogesterone tablets and reference preparation (R) dydrogesterone tablets (Davton®) in Chinese healthy female subjects after single oral administration on an empty stomach and after a meal.
随机、开放、两制剂、四周期、两序列重复交叉设计评估中国健康志愿者餐后状态下口服鲁比前列酮胶囊48 μg生物等效性试验
[Translation] A randomized, open-label, two-agent, four-cycle, two-sequence repeat crossover design to evaluate the bioequivalence of oral lubiprostone capsules 48 μg in Chinese healthy volunteers
以南京正大天晴制药有限公司研制的鲁比前列酮胶囊(规格:24μg)为受试制剂,Sucampo Pharma Americas,LLC.持证、Catalent Pharma Solutions, LLC.生产的鲁比前列酮胶囊(商品名:AMITIZA,规格:24μg)为参比制剂,研究受试制剂和参比制剂在餐后状态下给药时的药代动力学参数,进行人体生物等效性评价,并评估南京正大天晴制药有限公司研制的鲁比前列酮胶囊的安全性。
[Translation] Lubiprostone capsules (specification: 24 μg) developed by Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. were used as the test preparation, and Lubiprostone capsules (trade name) were licensed by Sucampo Pharma Americas, LLC. and produced by Catalent Pharma Solutions, LLC. : AMITIZA, specification: 24μg) as the reference preparation, to study the pharmacokinetic parameters of the test preparation and the reference preparation when administered in the postprandial state, conduct bioequivalence evaluation in humans, and evaluate Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. Safety of lubiprostone capsules developed by Co., Ltd.
[Translation] Pharmacokinetic study of lubiprostone capsules in Chinese healthy volunteers
以中国健康志愿者为试验对象,进行鲁比前列酮胶囊(南京正大天晴制药有限公司研制)24μg、48μg两个剂量的空腹单次给药药代动力学试验和48μg剂量的餐后单次给药药代动力学试验,以及48μg/日(前6日24μg/次、1日2次,第7日单次给药24μg)剂量的多次给药药代动力学试验,估算相应的药代动力学参数,评价鲁比前列酮胶囊在中国健康志愿者体内的药代动力学特征和安全性。
[Translation] Taking Chinese healthy volunteers as the test objects, the pharmacokinetic test of lubiprostone capsules (developed by Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.) of 24 μg and 48 μg in a single fasting dose and a single dose of 48 μg after meals were conducted. Dosing pharmacokinetic test, as well as multiple-dose pharmacokinetic test at a dose of 48 μg/day (24 μg/time on the first 6 days, twice a day, and a single dose of 24 μg on the 7th day) to estimate the corresponding drug Kinetic parameters to evaluate the pharmacokinetic characteristics and safety of lubiprostone capsules in healthy Chinese volunteers.
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