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