PAXIL CR Bioequivalence Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-07

Study Completion Date

2008-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Paxil CR Bioequivalence Study Brazil - Fed Administration

NCT01339247

Depressive Disorder

COMPLETED PHASE1

Paxil CR Bioequivalence Study Brazil

NCT01316926

Depressive Disorder

COMPLETED PHASE1

Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg

NCT00647881

Healthy

COMPLETED PHASE1

Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers

NCT03504475

Major Depressive Disorder Obsessive-Compulsive Disorder Panic Disorder +2 more

COMPLETED PHASE1

Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants

NCT04311463

Anxiety Disorders

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open label treatment

On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.

Group Type EXPERIMENTAL

Paxil CR

Intervention Type DRUG

Paxil CR 37mg tablet manufactures at two different sites

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paxil CR

Paxil CR 37mg tablet manufactures at two different sites

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.

Key Exclusion:

Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; \>14 drinks/week for men or \>7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Buffalo, New York, United States

Site Status

GSK Investigational Site

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.