Bioequivalence Study of Two Formulations of Tramadol Capsules in Healthy Myanmar Volunteers
Not Applicable
Recruiting
- Conditions
- BioequivalenceBioequivalanceBioavailabilityTramadolPharmacokineticsHigh Performance Liquid Chromatography (HPLC)
- Registration Number
- TCTR20190107001
- Lead Sponsor
- Implementation research grant (ID-197, 2018) from the Ministry of Health and Sports, Myanmar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
1.Age: 18-55 years
2.Sex: either sex
3.BMI: 18-30 kg/m2
4.Non-smoker
5.Non-drinker
6.Persons whose Chest X rays, Blood for complete picture, liver enzymes (ALT, AST), Electrocardiograph (ECG), Random Blood Sugar (RBS) and renal function test (urea, creatinine) are within normal limits at the beginning of the study
Exclusion Criteria
1.Subjects with history of allergic reactions to Tramadol
2.History of epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioequivalence 0,1,2,3,4,6,10,24 hours after administration, 2 periods with 2 week washout period Area under the concentration time curve (AUC), Maximum Concentration (Cmax) by HPLC
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters 0,1,2,3,4,6,10,24 hours after administration, 2 periods with 2 week washout period Time to reach maximal concentration (Tmax), half life (T1/2) by HPLC,Pharmacokinetic parameters 0,1,2,3,4,6,10,24 hours after administration, 2 periods with 2 week washout period elimination rate constant (Kel), volume of distribution (Vd), clearance (Cl) by HPLC