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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution; Drug: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: CRO's Office; Phone Number: +962 6 5627648; Email: clinicaltrials@unither-pharma.com

Study Locations

• Jordan
  • Amman, Jordan, 11196
    • IPRC reserach site facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0)	Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution; 50mg (10mL) single dose
Active Comparator: Tramadol hydrochloride 100mg/mL oral solution (Contramal(r))	Drug: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)); 50mg (20 drops) single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability questionnaire	5 point scale: from 1 : very bad after taste to 5 : very good after taste	0 and 2 minutes

Collaborators and Investigators

• Sponsor: Unither Pharmaceuticals, France
• Collaborators: International Pharmaceutical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): February 26, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Pharmaceutical Solutions; Tramadol
• Other Study ID Numbers: UP-CLI-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No