At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Tramadol Hydrochloride 5 MG/ML Oral Solution +1 moredrug
Likely dose
Tramadol Hydrochloride 5 MG/ML Oral Solutionfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Randomized, Single Dose, Two-Way Crossover Open Label Study To Determine The Bioequivalence Of 5 mg/mL Tramadol Hydrochloride Oral Solution (08P1902F0) Relative To Contramal® (100 mg/mL Oral Solution) After An Oral Administration
In Brief
A Phase 1 clinical trial evaluating Tramadol Hydrochloride 5 MG/ML Oral Solution and Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJordan
CollaboratorsInternational Pharmaceutical Research Center
Timeline
Phase 1CompletedFinished
202420252026
First PostedFeb 2023
Enrollment StartFeb 2023
Primary CompletionFeb 2023
Study CompletionFeb 2023
TodayJul 2026
First PostedFeb 8, 2023
Enrollment StartFeb 14, 2023
Primary CompletionFeb 26, 2023
Study CompletionFeb 27, 2023
TodayJul 2, 2026
Enrollment to primary: 12 daysPosted 3.4 years ago
Interventions
Tramadol Hydrochloride 5 MG/ML Oral Solutiondrug
50mg (10mL) single dose
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))drug
50mg (20 drops) single dose