NCT05716763

Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tramadol Hydrochloride 5 MG/ML Oral Solution	50mg (10mL) single dose
DRUG	Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))	50mg (20 drops) single dose

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-02-26
• Completion: 2023-02-27
• First posted: 2023-02-08
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

1 site across 1 country: Jordan