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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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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date22 Apr 1968 |
Target- |
Mechanism- |
Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
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] Bioequivalence trial of dihydrocodeine tartrate tablets in randomized, open-label, two-cycle, crossover healthy human subjects in the postprandial 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 purpose of this study was to compare the bioavailability of two dihydrocodeine tartrate 30 mg tablets in the postprandial state of healthy subjects and thereby 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 human subjects in fasting/postprandial state
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: In this study, calcitriol soft capsules (specification: 0.25 μg) developed by Aomei Pharmaceutical Factory were used as the test preparation. According to the relevant regulations of bioequivalence research, the original manufacturer Roche Pharma (Schweiz) Ltd. produced it. The calcitriol capsules (specification: 0.25 μg, trade name: Rogaiquan®) were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary research objectives: To observe the safety of the test preparation calcitriol soft capsules and the reference preparation calcitriol capsules (Luogaiquan®) 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-cycle, crossover bioequivalence trial of dihydrocodeine tartrate tablets in fasting/postprandial conditions in healthy humans
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 purpose of this study was to compare the bioavailability of two dihydrocodeine tartrate tablets 30 mg in healthy subjects in fasting and postprandial states 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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