Last updated: 11/04/2018 12:29:05
GSK372475 Bioequivalence Study
GSK study ID
SND110117
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Timeframe: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Secondary outcomes:
Adverse events
Timeframe: all visits
vitals (all visits) + ECG
Timeframe: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
labs
Timeframe: at screening and 2 weeks post dose
Interventions:
Drug: GSK372475
Enrollment:
66
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Depressive Disorder
Product
GSK372475
Collaborators
Not applicable
Study date(s)
July 2007 to November 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy Males/Females aged 18-45 years
- Non-smokers
- Use of oral contraception
- Positive breath alcohol and drug screen
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-05-11
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
Additional information
Not applicable
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