Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504475|
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Obsessive-Compulsive Disorder Panic Disorder Social Anxiety Disorder Generalized Anxiety Disorder||Drug: Paroxetine Hydrochloride Tablet 20 mg Drug: Paxil® 20 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Paroxetine Hydrochloride 20 mg Tablets and Paxil® Under Fasting Conditions and Under Fed Conditions in Chinese Healthy Volunteers|
|Actual Study Start Date :||March 29, 2018|
|Actual Primary Completion Date :||April 24, 2018|
|Actual Study Completion Date :||June 16, 2018|
Experimental: Paroxetine Hydrochloride Tablet
During the study session, healthy subjects will be administered a single dose of Paroxetine Hydrochloride Tablet 20mg under Fasting and Fed conditions.
Drug: Paroxetine Hydrochloride Tablet 20 mg
A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
Active Comparator: Paxil®
During the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions.
Drug: Paxil® 20 mg
Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.
Other Name: Paroxetine Hydrochloride Tablet 20 mg
- Cmax [ Time Frame: Blood samples collected over 96 hour period ]Maximum Observed Concentration (of Paroxetine in Plasma)
- AUC(0-∞) [ Time Frame: Blood samples collected over 96 hour period ]Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
- AUC(0-t) [ Time Frame: Blood samples collected over 96 hour period ]Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504475
|Beijing TongRen Hospital|
|Beijing, Beijing, China, 100730|
|Beijing TongRen Hospital|
|Principal Investigator:||Xiuli Zhao, PhD||Beijing Tongren Hospital|