Skip to main content
OpenTrials
Completed

NCT Number: NCT05716763

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IPRC reserach site facility

Amman, 11196, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol Hydrochloride 5 MG/ML Oral Solution

Drug

50mg (10mL) single dose

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

Drug

50mg (20 drops) single dose

Primary outcomes

  1. Cmax of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    The maximum concentration in plasma among observed concentrations at pre-specified time points

  2. AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    The area under the plasma concentration versus time curve from time 0 to the last measured concentration

Secondary outcomes

  1. AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    The area under the plasma concentration versus time curve from time 0 to to infinite time

  2. Kel of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    The elimination rate constant

  3. Tmax of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    Time of the maximum measured plasma concentration. Determined directly from the plasma concentration-time curve. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

  4. T1/2 of Tramadol Hydrochloride for the Test and the Reference Products

    Time frame: 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

    Plasma Elimination Half-Life

  5. Number of Treatment-related Adverse Events

    Time frame: Day 1 to Day 11 (end of study)

    Occurence and severity of adverse events (serious and non serious adverse events)

Other outcomes

  1. Palatability Questionnaire

    Time frame: 0 and 2 minutes

    5 point scale: from 1 : very bad after taste to 5 : very good after taste

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Collaborators

  • International Pharmaceutical Research Center

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.