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

NCT00938184 | Completed Phase 1

• 1 other identifier: 112811
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Disorder

Keywords

tolerance; single dose; paroxetine; controlled-release tablet; safety; pharmacokinetics; Japanese healthy male subjects

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of plasma paroxetine after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers

  up to 120 hours after a single dose in all dosing sessions

Secondary Outcomes (1)

• Safety and tolerability after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers

  up to 120 hours after a single dose in all dosing sessions

Study Arms (6)

Treatment sequence A/B/C

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Treatment sequence A/C/B

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Treatment sequence B/A/C

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Treatment sequence B/C/A

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Treatment sequence C/A/B

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Treatment sequence C/B/A

EXPERIMENTAL

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; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet

Interventions

Paroxetine 12.5 milligrams tablet DRUG

Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.

Treatment sequence A/B/C; Treatment sequence A/C/B; Treatment sequence B/A/C; Treatment sequence B/C/A; Treatment sequence C/A/B; Treatment sequence C/B/A

Paroxetine 25 milligrams tablet DRUG

Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.

Treatment sequence A/B/C; Treatment sequence A/C/B; Treatment sequence B/A/C; Treatment sequence B/C/A; Treatment sequence C/A/B; Treatment sequence C/B/A

Paroxetine 50 milligrams tablet DRUG

Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.

Treatment sequence A/B/C; Treatment sequence A/C/B; Treatment sequence B/A/C; Treatment sequence B/C/A; Treatment sequence C/A/B; Treatment sequence C/B/A

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 108-8642, Japan

Location

Related Links

• Results for study 112811 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: July 14, 2009
• Primary Completion: September 2, 2009
• Study Completion: September 2, 2009
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)