骨化三醇胶丸在中国健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉设计的生物等效性试验
[Translation] A randomized, open-label, fasting and postprandial single-dose, two-preparation, two-sequence, two-period crossover design bioequivalence trial of calcitriol capsules in Chinese healthy subjects
主要研究目的
研究空腹和餐后状态下单次口服骨化三醇胶丸(规格:0.25μg,大连美创药业有限公司)与参比制剂(规格:0.25μg,罗盖全®;持证商:Roche Pharma (Schweiz) AG)后骨化三醇在中国健康受试者体内的药代动力学(PK)特征,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂骨化三醇胶丸和参比制剂骨化三醇胶丸后的安全性。
[Translation] Main research purpose
Study single oral administration of calcitriol capsules (specification: 0.25 μg, Dalian Meichuang Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25 μg, Luo Gaiquan®; license holder: Roche) in fasting and postprandial states Pharma (Schweiz) AG) to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary research purpose
To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation calcitriol capsules and the reference preparation calcitriol capsules in fasting and postprandial states.
艾地骨化醇软胶囊在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性对比研究
[Translation] A randomized, open-label, fasting and postprandial single-dose, two-preparation, two-sequence, two-cycle crossover bioequivalence study of idecalcidol soft capsules in Chinese adult healthy subjects
主要研究目的:考察空腹/餐后条件下单次口服0.75μg受试制剂艾地骨化醇软胶囊(规格:0.75μg/粒,大连美创药业有限公司生产)与参比制剂艾地骨化醇软胶囊(商品名:EDIROL®,规格:0.75μg/粒,中外製薬株式会社生产)在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态分别口服两种制剂的生物等效性。
次要研究目的:评价受试制剂和参比制剂空腹/餐后条件下单次口服0.75μg在中国成年健康受试者中的安全性。
[Translation] Main research purpose: To investigate the effect of a single oral administration of 0.75 μg test preparation Aidicalcidol soft capsule (specification: 0.75 μg/capsule, produced by Dalian Meichuang Pharmaceutical Co., Ltd.) and reference preparation Aidigu under fasting/postprandial conditions. Pharmacokinetic characteristics of Hua Alcohol Soft Capsules (trade name: EDIROL®, specification: 0.75 μg/capsule, produced by Chuwai Pharmaceutical Co., Ltd.) in Chinese adult healthy subjects, evaluating the two preparations orally in fasting and postprandial states respectively bioequivalence.
Secondary research objectives: To evaluate the safety of a single oral dose of 0.75 μg of the test preparation and reference preparation under fasting/postprandial conditions in Chinese adult healthy subjects.
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