repeat dose study of controlled-release paroxetine tablets and immediate-release paroxetine tablets in healthy japanese male subjects

Conditions: Depressive Disorder

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.

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 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

Keywords: controlled-release tablet repeat dose immediate-release tablet paroxetine safety crossover pharmacokinetics steady-state japanese healthy male volunteers tolerance