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

• Status: Completed
• Trial end date: 2010-02-25
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

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