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

NCT05716763 | Completed Phase 1 Results

• 1 other identifier: UP-CLI-2021-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUC0-infinity 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

• Kel 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

• Tmax 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

• T1/2 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

• Number of Treatment-related Adverse Events

  Day 1 to Day 11 (end of study)

Other Outcomes (1)

• Palatability Questionnaire

  0 and 2 minutes

Study Arms (2)

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

EXPERIMENTAL

Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution

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

ACTIVE COMPARATOR

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

Interventions

Tramadol Hydrochloride 5 MG/ML Oral Solution DRUG

50mg (10mL) single dose

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

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

50mg (20 drops) single dose

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unither Pharmaceuticals, France: lead
• International Pharmaceutical Research Center: collaborator

Study Sites (1)

IPRC reserach site facility

Amman, 11196, Jordan

Location

MeSH Terms

Interventions

Tramadol; Solutions

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Pharmaceutical Preparations

Results Point of Contact

• Title: Non-clinical & clinical Project Manager
• Organization: Unither-Pharmaceuticals

clinicaltrials@unither-pharma.com

33 (0)1 44 63 51 78

Study Officials

• Majdi Abu Awida, M.D

  IPRC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, single dose, two-sequence, two-period crossover study

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: February 14, 2023
• Primary Completion: February 26, 2023
• Study Completion: February 27, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)