Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05716763
- Lead Sponsor
- Unither Pharmaceuticals, France
- Brief Summary
This study aims to demonstrate the bioequivalence between the formulation of 5 mg/mL Tramadol Hydrochloride Oral Solution (08P1902F0) Relative to the reference product Contramal® (100 mg/mL Oral Solution).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Male and non-pregnant female human subjects, age 18-50 years
- Body mass index between 18.5-30 Kg/m²
- Subject with normal findings
- Willingness to follow the protocol requirements
- History of hypersensitivity to tramadol hydrochloride
- Significant history of asthma, thyrotoxicosis, tumours, peptic or gastric ulcer, gastrointestinal malabsorption or haemorrhage in the gastro-intestinal tract, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder (ex. severe heart failure), neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders
- Presence of any clinically significant results from laboratory tests,
- lactating female or woman of childbearing potential unwilling to use an effective contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0) Tramadol Hydrochloride 5 MG/ML Oral Solution - Tramadol hydrochloride 100mg/mL oral solution (Contramal(r)) Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) -
- Primary Outcome Measures
Name Time Method Cmax of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours The area under the plasma concentration versus time curve from time 0 to the last measured concentration
- Secondary Outcome Measures
Name Time Method Tmax of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours Time of the maximum measured plasma concentration. Determined directly from the plasma concentration-time curve. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
T1/2 of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours Plasma Elimination Half-Life
AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours The area under the plasma concentration versus time curve from time 0 to to infinite time
Kel of Tramadol Hydrochloride for the Test and the Reference Products predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours The elimination rate constant
Number of Treatment-related Adverse Events Day 1 to Day 11 (end of study) Occurence and severity of adverse events (serious and non serious adverse events)
Trial Locations
- Locations (1)
IPRC reserach site facility
🇯🇴Amman, Jordan