Comparative study on the bioequivalence of two different gabapentin 300mg formulations (Sobhan daru & reference) in 24 iranian volunteers
Not Applicable
- Conditions
- Health and normal volunteers.--
- Registration Number
- IRCT201511058022N3
- Lead Sponsor
- Sobhan Daru pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
24 healthy male and female volunteers will participate in this study. Aged 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW
Exclusion criteria:
Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: hour. Method of measurement: blood sampling.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters. Timepoint: after intervention. Method of measurement: theoretical and pahrmacokinetic equations.