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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716763
• Other study ID #: UP-CLI-2021-001
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2023
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: Unither Pharmaceuticals, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 27, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tramadol Hydrochloride 5 MG/ML Oral Solution
50mg (10mL) single dose
• Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
50mg (20 drops) single dose

Locations

Country	Name	City	State
Jordan	IPRC reserach site facility	Amman

Sponsors (2)

Lead Sponsor	Collaborator
Unither Pharmaceuticals, France	International Pharmaceutical Research Center

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Palatability questionnaire	5 point scale: from 1 : very bad after taste to 5 : very good after taste	0 and 2 minutes
Primary	Cmax of tramadol hydrochloride for the test and the reference products	The maximum concentration in plasma among observed concentrations at pre-specified time points	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
Primary	AUC0-t of tramadol hydrochloride for the test and the reference products	The area under the plasma concentration versus time curve from time 0 to the last measured concentration	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	AUC0-infinity of tramadol hydrochloride for the test and the reference products	The area under the plasma concentration versus time curve from time 0 to to infinite time	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	Kel of tramadol hydrochloride for the test and the reference products	The elimination rate constant	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	Tmax of tramadol hydrochloride for the test and the reference products	Plasma Elimination Half-Life	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	T1/2 of tramadol hydrochloride for the test and the reference products	Plasma Elimination Half-Life	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	Incidence of treatment-related adverse events	Occurence and severity of adverse events (serious and non serious adverse events)	Day 1 to Day 11 (end of study)