Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Paroxetine CR and Paroxetine IR
Sponsored by
About this trial
This is an interventional other trial for Depressive Disorder focused on measuring controlled-release tablet, repeat dose, immediate-release tablet, paroxetine, safety, crossover, pharmacokinetics, steady-state, Japanese healthy male volunteers, tolerance
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 Type
Experimental
Arm Label
Open label treatment with 2-period crossover design
Arm Description
Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days. Group 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days., PK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period.
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day
Secondary Outcome Measures
Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000857
Brief Title
Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2009 (Actual)
Primary Completion Date
February 25, 2010 (Actual)
Study Completion Date
February 25, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
controlled-release tablet, repeat dose, immediate-release tablet, paroxetine, safety, crossover, pharmacokinetics, steady-state, Japanese healthy male volunteers, tolerance
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label treatment with 2-period crossover design
Arm Type
Experimental
Arm Description
Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days.
Group 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days.,
PK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period.
Intervention Type
Drug
Intervention Name(s)
Paroxetine CR and Paroxetine IR
Intervention Description
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
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day
Time Frame
up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR
Secondary Outcome Measure Information:
Title
Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR
Time Frame
During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112812
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112812
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112812
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112812
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
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