Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Depressive Disorder
About this trial
This is an interventional other trial for Depressive Disorder focused on measuring tolerance, single dose, paroxetine, controlled-release tablet, safety, pharmacokinetics, Japanese healthy male subjects
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Treatment sequence A/B/C
Treatment sequence A/C/B
Treatment sequence B/A/C
Treatment sequence B/C/A
Treatment sequence C/A/B
Treatment sequence C/B/A
Eligible subjects will be randomized in sequence A/B/C and will receive A: single tablet of paroxetine 12.5 milligrams, B: single tablet of paroxetine 25 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Eligible subjects will be randomized in sequence A/C/B and will receive A: single tablet of paroxetine 12.5 milligrams, C: two tablets of paroxetine 25 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Eligible subjects will be randomized in sequence B/A/C and will receive B: single tablet of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Eligible subjects will be randomized in sequence B/C/A and will receive B: single tablet of paroxetine 25 milligrams, C: two tablets of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Eligible subjects will be randomized in sequence C/A/B and will receive C: two tablets of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Eligible subjects will be randomized in sequence C/B/A and will receive C: two tablets of paroxetine 25 milligrams, B: single tablet of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.