Depressive Disorder
Conditions
Keywords
controlled-release tablet, repeat dose, immediate-release tablet, paroxetine, safety, crossover, pharmacokinetics, steady-state, Japanese healthy male volunteers, tolerance
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.
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.
Interventions
DRUGParoxetine 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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed