Phase 1
Completed N=24
Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
Healthy
Source: ClinicalTrials.gov NCT05716763 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Cmax of Tramadol Hydrochloride for the Test and the Reference Products — 139.65; 123.90 ng/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Tramadol Hydrochloride for the Test and the Reference Products |
139.65; 123.90 | — |
| PRIMARY AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products |
902.01; 812.63 | — |
| SECONDARY AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products |
965.92; 873.74 | — |
| SECONDARY Kel of Tramadol Hydrochloride for the Test and the Reference Products |
0.1344; 0.1294 | — |
| SECONDARY Tmax of Tramadol Hydrochloride for the Test and the Reference Products |
1.5; 1 | — |
| SECONDARY T1/2 of Tramadol Hydrochloride for the Test and the Reference Products |
5.48; 5.71 | — |
| SECONDARY Number of Treatment-related Adverse Events |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05716763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.