Healthy Subjects Clinical Trial
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.
NCT number | NCT00488098 |
Other study ID # | SND110117 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | June 15, 2007 |
Last updated | May 31, 2012 |
Start date | July 2007 |
Verified date | February 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Therapeutic Products Directorate |
Study type | Interventional |
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
Status | Completed |
Enrollment | 66 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax | at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose. | ||
Secondary | Adverse events | all visits | ||
Secondary | vitals (all visits) + ECG | at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose. | ||
Secondary | labs | at screening and 2 weeks post dose |
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