Clinical trial

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

Name

UP-CLI-2021-001

Description

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).

Trial arms

Trial start

2023-02-14

Estimated PCD

2023-02-26

Trial end

2023-02-27

Status

Completed

Phase

Early phase I

Treatment

Tramadol Hydrochloride 5 MG/ML Oral Solution

50mg (10mL) single dose

Arms:

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

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

50mg (20 drops) single dose

Arms:

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

Size

Primary endpoint

Cmax of tramadol hydrochloride for the test and the reference products

predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours

AUC0-t of tramadol hydrochloride for the test and the reference products

predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open-label, randomized, single dose, two-sequence, two-period crossover study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2023-04-12

1 organization

1 product

1 indication

Product

Tramadol Hydrochloride

Indication

Healthy

Organization

Unither Pharmaceuticals