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

NCT05716763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-16

Study results available
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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

Interventions

DRUG

Tramadol Hydrochloride 5 MG/ML Oral Solution

50mg (10mL) single dose

DRUG

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

50mg (20 drops) single dose

Sponsors & Collaborators

  • International Pharmaceutical Research Center

    collaborator OTHER

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Principal Investigators

  • Majdi Abu Awida, M.D · IPRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-02-26
Completion
2023-02-27

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716763 on ClinicalTrials.gov