Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

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:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tramadol Hydrochloride 5 MG/ML Oral Solution intervention 2: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
Intervention descriptions: intervention 1: 50mg (10mL) single dose intervention 2: 50mg (20 drops) single dose

Protocol document:
Prot_SAP_000.pdf: