Last updated: 11/07/2018 05:15:40
Repeat Dose Study of Controlled-Release Paroxetine tablets and Immediate-Release Paroxetine tablets in Healthy Japanese Male Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A steady-state, two-period crossover study to compare the pharmacokinetic profile of paroxetine after repeated daily dosing of the controlled-release paroxetine tablet (25 mg) with that of the standard immediate-release paroxetine tablet (20 mg) in healthy Japanese male subjects
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day
Timeframe: up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR
Secondary outcomes:
Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR
Timeframe: During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR
Interventions:
Drug: Paroxetine CR and Paroxetine IR
Enrollment:
26
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Uemura S., Wakamatsu A., Nohda S., Sakamoto T., Hirama T.. Results of Clinical Pharmacokinetics Studies of Paroxetine Controlled-Release Tablet (Paroxetine CR) in Japanese Subjects. Japan J Clin Psychopharm. 2012;15(5):749-765.
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
November 2009 to February 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 64 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-25-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 112812 can be found on the GSK Clinical Study Register.
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