PAXIL CR Bioequivalence Study

An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Paxil CR

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14202
      • GSK Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98418
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open label treatment; On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.	Drug: Paxil CR; Paxil CR 37mg tablet manufactures at two different sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Paroxetine blood levels	measured up to 168 hours after a single dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs	measured up to 168 hours after a single dose and throughout study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2008
• Primary Completion (Actual): September 16, 2008
• Study Completion (Actual): September 16, 2008

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: paroxetine; healthy volunteers
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: PCR111656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: PCR111656
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register