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

Unither Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)); Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05716763

UP-CLI-2021-001

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0)

Experimental group

Treatment:

Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution

Tramadol hydrochloride 100mg/mL oral solution (Contramal(r))

Active Comparator group

Treatment:

Drug: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))