Back to resultsGSK372475 Bioequivalence Study
Primary Purpose
Healthy Subjects, Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GSK372475
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects focused on measuring Healthy Bioequivalence
Eligibility Criteria
Inclusion Criteria:
- Healthy Males/Females aged 18-45 years
- Non-smokers
- BMI 19-30 kg.m2
- QTc<450msec
Exclusion Criteria:
- Use of oral contraception
- Positive breath alcohol and drug screen
- Regular alcohol consumption
- Current psychiatric illness or within 1 year.
- History of GI, hepatic or renal disease
- Uncontrolled hypertension
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Secondary Outcome Measures
Adverse events
vitals (all visits) + ECG
labs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488098
Brief Title
GSK372475 Bioequivalence Study
Official Title
An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
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 study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Depressive Disorder
Keywords
Healthy Bioequivalence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK372475
Primary Outcome Measure Information:
Title
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Time Frame
at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
all visits
Title
vitals (all visits) + ECG
Time Frame
at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
Title
labs
Time Frame
at screening and 2 weeks post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Males/Females aged 18-45 years
Non-smokers
BMI 19-30 kg.m2
QTc<450msec
Exclusion Criteria:
Use of oral contraception
Positive breath alcohol and drug screen
Regular alcohol consumption
Current psychiatric illness or within 1 year.
History of GI, hepatic or renal disease
Uncontrolled hypertension
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
Toronto
State/Province
Ontario
ZIP/Postal Code
M1L 4S4
Country
Canada
12. IPD Sharing Statement
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GSK372475 Bioequivalence Study
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