Bioequivalance study of Tramadole 100 mg Tablets
Not Applicable
- Conditions
- Bioequivalance Tramadole 100 mg.
- Registration Number
- IRCT20200513047423N7
- Lead Sponsor
- Shahrdaru Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy kidney
Volunteers should not be too fat or too thin and their weight index should be in the appropriate range
Exclusion Criteria
Out of age ranges
smoking
pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration changing after administration of Tramadole 100 mg tablet.Plasma concentration of Tramadole at Tmax reaches about 350 ng/mL and its measurement range is from 10ng / mL to 1000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Tramadole is between 1 and 2 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of Tramadole. High performance liquid chromatography is used to determine the concentration of Tramadole in plasma.
- Secondary Outcome Measures
Name Time Method