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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.GB |
First Approval Date01 Jan 1990 |
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MechanismBacterial IRS inhibitors |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date31 Dec 1987 |
在健康志愿者的空腹和进食状态下,GSKT和Mississauga生产的帕罗西汀速释片的随机,开放性,双侧交叉生物等效性研究
[Translation] A randomized, open-label, two-sided crossover bioequivalence study of paroxetine immediate-release tablets manufactured by GSKT and Mississauga in healthy volunteers in fasting and fed states
主要目的:
在健康志愿者的空腹和进食状态下,评估GSKT和Mississauga生产的帕罗西汀IR片的生物等效性
次要目的:
评估在中国健康受试者中,帕罗西汀IR片的安全性和耐受性。
获得在中国健康受试者中,帕罗西汀IR片的药代动力学概况
[Translation] main purpose:
Evaluation of bioequivalence of paroxetine IR tablets produced by GSKT and Mississauga in fasting and fed states in healthy volunteers
Secondary purpose:
To evaluate the safety and tolerability of paroxetine IR tablets in healthy Chinese subjects.
To obtain a pharmacokinetic profile of paroxetine IR tablets in healthy Chinese subjects
A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
100 Clinical Results associated with Sino-American Tianjin Smith Kline & French Laboratories Ltd.
0 Patents (Medical) associated with Sino-American Tianjin Smith Kline & French Laboratories Ltd.
100 Deals associated with Sino-American Tianjin Smith Kline & French Laboratories Ltd.
100 Translational Medicine associated with Sino-American Tianjin Smith Kline & French Laboratories Ltd.