clinical trial · NCT05716763
Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
Unither Pharmaceuticals, France·phase1·completed·n = 24
HealthyTramadol Hydrochloride 5 MG/ML Oral SolutionTramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
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).
started
Feb 14, 2023
primary completion
Feb 26, 2023
completion
Feb 27, 2023
last updated
Dec 16, 2024
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol