HealthyPhase 1NCT05716763
Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
A Phase 1 study testing Tramadol Hydrochloride 5 MG/ML Oral Solution and Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) in people with Healthy, run by Unither Pharmaceuticals, France at 1 site in Jordan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tramadol Hydrochloride 5 MG/ML Oral Solution and Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 14 Feb 2023to 27 Feb 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Tramadol Hydrochloride 5 MG/ML Oral Solution, Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Hydrochloride 5 MG/ML Oral SolutionDrug
50mg (10mL) single dose
Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))Drug
50mg (20 drops) single dose
| Study group | Role | What they receive |
|---|---|---|
| Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0) | Experimental | Not described Receives: Drug: Tramadol Hydrochloride 5 MG/ML Oral Solution |
| Tramadol hydrochloride 100mg/mL oral solution (Contramal(r)) | Active comparator | Not described Receives: Drug: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Tramadol Hydrochloride for the Test and the Reference Products
The maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: 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
Measured: 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
The area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: 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
Measured: 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
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.
Measured: 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
Measured: 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
Occurence and severity of adverse events (serious and non serious adverse events)
Measured: Day 1 to Day 11 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Feb 2023
- Primary completion26 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, single dose, two-sequence, two-period crossover study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Pharmaceutical Research Center
- Responsible party
- Sponsor
- Investigators
- Majdi Abu Awida, M.D, Principal investigator, IPRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716763
- Sponsor's protocol ID
- UP-CLI-2021-001
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2023
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05716763
- Acronym / sponsor ID
- UP-CLI-2021-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Collaborators
- International Pharmaceutical Research Center
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 26 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized, single dose, two-sequence, two-period crossover study
| Arm | Type | Receives |
|---|---|---|
| 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)) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol Hydrochloride 5 MG/ML Oral Solution50mg (10mL) single dose | Drug | Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0) |
| Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))50mg (20 drops) single dose | Drug | Tramadol hydrochloride 100mg/mL oral solution (Contramal(r)) |
Primary outcome
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
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
5 secondary outcomes
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
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
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
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
Number of Treatment-related Adverse Events
Time frame: Day 1 to Day 11 (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Majdi Abu Awida, M.D principal investigator
IPRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol Hydrochloride 5 MG/ML Oral Solution and Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) in people with Healthy, run by Unither Pharmaceuticals, France at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.