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Mechanismfungal CYP51A1 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date03 Feb 1975 |
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Active Indication- |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date22 Apr 1968 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseClinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
酒石酸双氢可待因片随机、开放、两周期、交叉健康人体餐后状态下生物等效性试验
[Translation] A randomized, open-label, two-period, crossover bioequivalence study of dihydrocodeine tartrate tablets in healthy volunteers in the fed state
本研究目的是比较两种酒石酸双氢可待因 30 毫克片剂在健康受试者餐后状态下的生物利用度,从而评估制剂的生物等效性。
[Translation] The aim of this study was to compare the bioavailability of two dihydrocodeine tartrate 30 mg tablets in healthy volunteers in the fed state and to evaluate the bioequivalence of the formulations.
骨化三醇软胶囊(0.25 μg)在空腹/餐后状态下健康人体生物等效性研究
[Translation] Bioequivalence study of calcitriol soft capsules (0.25 μg) in healthy volunteers under fasting/fed conditions
主要目的:本研究以澳美制药厂研发的骨化三醇软胶囊(规格:0.25 μg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Roche Pharma (Schweiz) Ltd.生产的骨化三醇胶丸(规格:0.25 μg,商品名:罗盖全®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要研究目的:观察受试制剂骨化三醇软胶囊和参比制剂骨化三醇胶丸(罗盖全®)在健康受试者中的安全性。
[Translation] Main purpose: This study uses the calcitriol soft capsule (specification: 0.25 μg) developed by Aome Pharmaceuticals as the test preparation. According to the relevant regulations of bioequivalence studies, the calcitriol capsule (specification: 0.25 μg, trade name: Roche Pharma (Schweiz) Ltd.) produced by the original manufacturer is used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary study objectives: To observe the safety of the test preparation calcitriol soft capsule and the reference preparation calcitriol capsule (Roche Pharma®) in healthy subjects.
酒石酸双氢可待因片随机、开放、两周期、交叉健康人体空腹/餐后状态下生物等效性试验
[Translation] A randomized, open-label, two-period, crossover bioequivalence study of dihydrocodeine tartrate tablets in healthy volunteers under fasting and fed conditions
本研究目的是比较两种酒石酸双氢可待因片30毫克在健康受试者空腹及餐后状态下的生物利用度,从而评估制剂的生物等效性。
[Translation] The aim of this study was to compare the bioavailability of two dihydrocodeine tartrate tablets 30 mg in healthy volunteers in the fasting and fed state and to evaluate the bioequivalence of the formulations.
100 Clinical Results associated with Hong Kong Aomei Pharmaceutical Factory Co., Ltd. Beijing Representative Office
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