/ CompletedNot Applicable 骨化三醇软胶囊在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of calcitriol soft capsules in healthy volunteers under fasting/fed conditions
主要研究目的:本研究以珠海健福制药有限公司持证的骨化三醇软胶囊(规格:0.25μg)为受试制剂,Atnahs Pharma UK Limited 持证的骨化三醇胶丸(商品名:罗盖全®,规格:0.25μg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study uses the calcitriol soft capsules (specification: 0.25μg) certified by Zhuhai Jianfu Pharmaceutical Co., Ltd. as the test preparation and the calcitriol capsules (trade name: Luogaiquan®, specification: 0.25μg) certified by Atnahs Pharma UK Limited as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
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