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

NCT ID: NCT05716763

Last Updated: 2024-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2023-02-27

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Open-label, randomized, single dose, two-sequence, two-period crossover study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Tramadol Hydrochloride 5 MG/ML Oral Solution

Intervention Type DRUG

50mg (10mL) single dose

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

50mg (20 drops) single dose

Interventions

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Tramadol Hydrochloride 5 MG/ML Oral Solution

50mg (10mL) single dose

Intervention Type DRUG

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

50mg (20 drops) single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Pharmaceutical Research Center

OTHER

Sponsor Role collaborator

Unither Pharmaceuticals, France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Majdi Abu Awida, M.D

Role: PRINCIPAL_INVESTIGATOR

IPRC

Locations

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IPRC reserach site facility

Amman, , Jordan

Site Status

Countries

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Jordan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UP-CLI-2021-001

Identifier Type: -

Identifier Source: org_study_id