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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000857
First received: October 22, 2009
Last updated: April 5, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Healthy Volunteer
Drug: Paroxetine CR and Paroxetine IR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Steady-state, Two-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Repeated Daily Dosing of the Controlled-release Paroxetine Tablet (25 mg) With That of the Standard Immediate-release Paroxetine Tablet (20 mg) 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 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day [ Time Frame: up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR [ Time Frame: During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label treatment with 2-period crossover design

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
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

Detailed Description:

This study is an open, randomized, repeat dose, two-period crossover design in Japanese healthy male volunteers. This clinical trial is designed primarily to compare the steady-state pharmacokinetic profile of paroxetine CR at the dosage of 25mg /day (25mg once daily for 14 days) using the proposed final market tablet of CR 25mg in Japan with that of paroxetine IR at the dosage of 20mg/day (20mg once daily for 14 days) using the currently marketed IR 20mg tablet in Japan, by the crossover oral repeat dosing manner.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000857

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01000857     History of Changes
Other Study ID Numbers: 112812
Study First Received: October 22, 2009
Last Updated: April 5, 2012
Health Authority: Japan: Pharmaceutical and Medical Device Agency

Keywords provided by GlaxoSmithKline:
safety
Japanese healthy male volunteers
repeat dose
crossover
controlled-release tablet
immediate-release tablet
paroxetine
pharmacokinetics
steady-state
tolerance

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014