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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date28 Jun 2013 |
托吡司特缓释片与托吡司特片在健康参与者中单次给药的药代动力学对比研究
[Translation] Comparative study of the pharmacokinetics of topiramate extended-release tablets and topiramate tablets after single administration in healthy subjects
主要目的:
(1)观察在健康参与者中空腹和餐后分别单次给与托吡司特缓释片,食物对托
吡司特缓释片的药代动力学影响;
(2)比较受试制剂托吡司特缓释片和参比制剂托吡司特片(商品名:
Topiloric®)在中国健康参与者中空腹和餐后口服给药后药代动力学特征。
次要目的:
观察托吡司特缓释片和托吡司特片在健康人体中的安全性。
[Translation] Primary objectives: (1) To observe the effect of food on the pharmacokinetics of topiramate extended-release tablets after single administration on an empty stomach or after a meal in healthy subjects; (2) To compare the pharmacokinetic characteristics of the test formulation topiramate extended-release tablets and the reference formulation topiramate tablets (trade name: Topiloric®) after oral administration on an empty stomach or after a meal in healthy Chinese subjects. Secondary objectives: To observe the safety of topiramate extended-release tablets and topiramate tablets in healthy subjects.
托吡司特缓释片与托吡司特片在健康参与者中多次给药的药代动力学对比研究
[Translation] Comparative study of the pharmacokinetics of topiramate extended-release tablets and topiramate tablets after repeated administration in healthy participants
主要目的:
比较受试制剂托吡司特缓释片和参比制剂托吡司特片(商品名:Topiloric®)
在中国健康成年参与者中多次餐后口服给药后药代动力学特征。
次要目的:
(1)比较受试制剂托吡司特缓释片和参比制剂托吡司特片(商品名:
Topiloric®)在中国健康成年参与者中多次餐后口服给药后药效动力学特征;
(2)观察托吡司特缓释片和托吡司特片在健康人体中的安全性。
[Translation] Primary objectives: To compare the pharmacokinetic characteristics of the test formulation, topiramate extended-release tablets, and the reference formulation, topiramate tablets (trade name: Topiloric®), after multiple oral administration in healthy Chinese adults. Secondary objectives: (1) To compare the pharmacodynamic characteristics of the test formulation, topiramate extended-release tablets, and the reference formulation, topiramate tablets (trade name: Topiloric®), after multiple oral administration in healthy Chinese adults; (2) To observe the safety of topiramate extended-release tablets and topiramate tablets in healthy humans.
/ Not yet recruitingPhase 1 托吡司特缓释片在健康参与者中单次给药的剂量比例关
系研究
[Translation] Dose-proportioning studies of topiramate extended-release tablets in healthy participants after a single dose.
主要目的:
观察在健康参与者中单次给予不同剂量的托吡司特缓释片,其活性成分托吡司特药代动力学(PK)特征的剂量比例关系。
次要目的:
观察托吡司特缓释片在健康人体中的安全性。
[Translation] Primary objective: To observe the dose-proportion relationship of the pharmacokinetic (PK) characteristics of the active ingredient, topiramate, after a single administration of different doses of topiramate extended-release tablets in healthy participants.
Secondary objective: To observe the safety of topiramate extended-release tablets in healthy human subjects.
100 Clinical Results associated with Shanghai Qihang Pharmaceutical Technology Dev Co., Ltd.
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