Last updated: 11/03/2018 11:18:00
Relative Bioavailability study for GSK1838262 (gabapentin enacarbil)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label, randomized, single dose, five-period crossover study to evaluate the relative bioavailability of different formulations of GSK1838262 in healthy volunteers.
Trial description: The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
gabapentin concentrations in blood
Timeframe: measured up to 36 hr after dosing
Secondary outcomes:
Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.
Timeframe: throughout the study
gabapentin concentrations in urine
Timeframe: measured up to 36 hr after dosing
Interventions:
Drug: open label
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neuropathy, Diabetic
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
January 2009 to March 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Year
Accepts healthy volunteers
yes
- healthy, male and female subjects aged between 18 and 65 years old.
- normal body weight.
- positive blood alcohol or urine drug test.
- positive hepatitis B/C and HIV
Inclusion and exclusion criteria
Inclusion criteria:
- healthy, male and female subjects aged between 18 and 65 years old.
- normal body weight.
- normal ECG, vital signs and lab tests.
- normal kidney function
- agree to use acceptable contraceptive methods required.
- capable of giving written informed consent.
Exclusion criteria:
- positive blood alcohol or urine drug test.
- positive hepatitis B/C and HIV
- donation of more than 450 mL blood within the 56 days.
- sensitivity to gabapentin
- pregnant or lactating females
- smoker
- certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
- history of seizure
Trial location(s)
No location data available.
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
2009-12-03
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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