Clinical trial NCT05716763: Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Unither Pharmaceuticals, France
Sponsor class: INDUSTRY
Collaborators: name: International Pharmaceutical Research Center
First posted: 2023-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label, randomized, single dose, two-sequence, two-period crossover study
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Cmax of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
measure: AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
Secondary outcomes:
measure: AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
measure: Kel of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
measure: Tmax of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
measure: T1/2 of Tramadol Hydrochloride for the Test and the Reference Products
timeFrame: 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
measure: Number of Treatment-related Adverse Events
timeFrame: Day 1 to Day 11 (end of study)
Other outcomes:
measure: Palatability Questionnaire
timeFrame: 0 and 2 minutes
Locations:
city: Amman
country: Jordan
facility: IPRC reserach site facility
Study officials:
affiliation: IPRC
name: Majdi Abu Awida, M.D
role: PRINCIPAL_INVESTIGATOR
References: