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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
July 9, 2009
July 13, 2009
July 7, 2017
July 14, 2009
September 2, 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00938184 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Depressive Disorder
  • 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/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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
  • 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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
  • 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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
  • 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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
  • 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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
  • 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.
    Interventions:
    • Drug: Paroxetine 12.5 milligrams tablet
    • Drug: Paroxetine 25 milligrams tablet
    • Drug: Paroxetine 50 milligrams tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2, 2009
September 2, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00938184
112811
No
Not Provided
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://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP