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Overview

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 study objectives To study the pharmacokinetic (PK) characteristics of calcitriol in healthy Chinese subjects after a single oral administration of calcitriol capsules (specification: 0.25μg, Dalian Meichuang Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25μg, Rogaquan®; licensee: Roche Pharma (Schweiz) AG) in fasting and fed states, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives To evaluate the safety of the test preparation calcitriol capsules and reference preparation calcitriol capsules in healthy Chinese subjects after a single oral administration in fasting and fed states.

Start Date12 Jul 2024

Sponsor / Collaborator

Dalian Meichuang Pharmacy Co., Ltd.

CTR20240248 / RecruitingNot Applicable

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, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of calcitriol softgels in healthy Chinese 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 study objectives To study the pharmacokinetic (PK) characteristics of calcitriol in healthy Chinese subjects after a single oral administration of calcitriol capsules (specification: 0.25μg, Dalian Meichuang Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25μg, Rogaquan®; licensee: Roche Pharma (Schweiz) AG) in fasting and fed states, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives To evaluate the safety of the test preparation calcitriol capsules and reference preparation calcitriol capsules in healthy Chinese subjects after a single oral administration in fasting and fed states.

Start Date26 Mar 2024

Sponsor / Collaborator

Dalian Meichuang Pharmacy Co., Ltd.

CTR20213333 / CompletedNot Applicable

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, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of adecalcitol soft capsules in healthy Chinese adult 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 single oral administration of 0.75 μg test preparation Idecalcidol soft capsule (specification: 0.75 μg/capsule, produced by Dalian Meichuang Pharmaceutical Co., Ltd.) and the reference preparation Idecalcidol under fasting/postprandial conditions. Pharmacokinetic characteristics of Huachol soft capsule (trade name: EDIROL®, specification: 0.75μg/capsule, manufactured by Chugai Seiko Co., Ltd.) in Chinese adult healthy subjects were evaluated after oral administration in fasting and postprandial states. Bioequivalence of formulations. Secondary study purpose: To evaluate the safety of a single oral dose of 0.75 μg of the test preparation and reference preparation in Chinese adult healthy subjects under fasting/postprandial conditions.

Start Date13 Jan 2022

Sponsor / Collaborator

Dalian Meichuang Pharmacy Co., Ltd.

100 Clinical Results associated with Dalian Meichuang Pharmacy Co., Ltd.

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