Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects

NCT01000857 | Completed Phase 1

• 1 other identifier: 112812
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to compare the steady-state pharmacokinetic profile of paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.

Conditions

Depressive Disorder

Keywords

controlled-release tablet; repeat dose; immediate-release tablet; paroxetine; safety; crossover; pharmacokinetics; steady-state; Japanese healthy male volunteers; tolerance

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day

  up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR

Secondary Outcomes (1)

• Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR

  During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR

Study Arms (1)

Open label treatment with 2-period crossover design

EXPERIMENTAL

Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days. Group 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days., PK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period.

Drug: Paroxetine CR and Paroxetine IR

Interventions

Paroxetine CR and Paroxetine IR DRUG

Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers

Open label treatment with 2-period crossover design

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 112812 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: October 22, 2009
• First Posted: October 23, 2009
• Study Start: November 5, 2009
• Primary Completion: February 25, 2010
• Study Completion: February 25, 2010
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)