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Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938184
First Posted: July 13, 2009
Last Update Posted: July 7, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese male volunteers.

Condition Intervention Phase
Depressive Disorder Drug: Paroxetine 12.5 milligrams tablet Drug: Paroxetine 25 milligrams tablet Drug: Paroxetine 50 milligrams tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label, Randomized, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Doses of the Controlled-release Paroxetine Tablets at the Dose Levels of 12.5, 25 and 50mg in Healthy Japanese Male Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic parameters of plasma paroxetine after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers [ Time Frame: up to 120 hours after a single dose in all dosing sessions ]

Secondary Outcome Measures:
  • Safety and tolerability after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers [ Time Frame: up to 120 hours after a single dose in all dosing sessions ]

Enrollment: 18
Actual Study Start Date: July 14, 2009
Study Completion Date: September 2, 2009
Primary Completion Date: September 2, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence A/B/C
Eligible subjects will be randomized in sequence A/B/C and will receive A: single tablet of paroxetine 12.5 milligrams, B: single tablet of paroxetine 25 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Experimental: Treatment sequence A/C/B
Eligible subjects will be randomized in sequence A/C/B and will receive A: single tablet of paroxetine 12.5 milligrams, C: two tablets of paroxetine 25 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Experimental: Treatment sequence B/A/C
Eligible subjects will be randomized in sequence B/A/C and will receive B: single tablet of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Experimental: Treatment sequence B/C/A
Eligible subjects will be randomized in sequence B/C/A and will receive B: single tablet of paroxetine 25 milligrams, C: two tablets of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Experimental: Treatment sequence C/A/B
Eligible subjects will be randomized in sequence C/A/B and will receive C: two tablets of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Experimental: Treatment sequence C/B/A
Eligible subjects will be randomized in sequence C/B/A and will receive C: two tablets of paroxetine 25 milligrams, B: single tablet of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 25 milligrams tablet
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.

Detailed Description:
This clinical trial is to characterize the pharmacokinetic profile after single oral doses of the proposed final market tablet formulations of paroxetine CR in Japan (the 12.5mg and 25mg tablets), at the dose levels of 12.5, 25 and 50mg in the healthy male Japanese volunteers. Treatment sequence of the 3 dose levels in each subject is randomized.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese adult males between 20 and 64 years of age inclusive
  • BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher
  • Non-smokers
  • AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range
  • QTc(B) interval <450 msec
  • Able to attend all visits and complete the study
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

  • Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests
  • Medical history that is not considered as eligible for inclusion in this study by the investigator
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones)
  • History of psychiatric disorder or suicide attempts or behaviours
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • History of sensitivity to any of the paroxetine formulations, or components thereof
  • Positive for urine drug screening
  • Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device
  • Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication
  • History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms
  • History of drug abuse, or current conditions of drug abuse or alcoholism
  • History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 150 mL of wine or 350 mL of beer or 45 mL of 80 proof distilled spirits) within 6 months of screening
  • Use of prescription or no-prescription drugs, including vitamins, crude drug, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication
  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Consumption of grapefruit or grapefruit-containing products from 7 days prior to the first dose of study medication
  • Positive for syphilis, HIV antibody and antigen, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody
  • Donation of blood in excess of 400mL within the previous 4 months or 200mL within the previous 1 month to the first dose of study medication
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00938184


Locations
Japan
GSK Investigational Site
Tokyo, Japan, 108-8642
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112811
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112811
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112811
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112811
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00938184     History of Changes
Other Study ID Numbers: 112811
First Submitted: July 9, 2009
First Posted: July 13, 2009
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
tolerance
single dose
paroxetine
controlled-release tablet
safety
pharmacokinetics
Japanese healthy male subjects

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors