Bioequivalence Bioequivalance Bioavailability Tramadol Pharmacokinetics High Performance Liquid Chromatography (HPLC)
Conditions
Interventions
Reference formulation,
tramadol 100 mg (two 50 mg capsules) single dose,Test formulation,
tramadol 100 mg (two 50 mg capsules) single dose
Active Comparator Drug,Active Comparator Drug
Reference,Test
Sponsors
Implementation research grant (ID-197, 2018) from the Ministry of Health and Sports, Myanmar
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
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
Exclusion criteria: 1. Subjects with history of allergic reactions to Tramadol 2. History of epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Myanmar
Contacts
Public ContactYe Htut Linn
Department of Pharmacology, University of Medicine 1, Yangon
Outcome results
None listed