BioequivalencePhase 1NCT03646331
Bioequivalence of Imeglimin Tablet Formulations
A Phase 1 study testing Imeglimin Reference product and Imeglimin in people with Bioequivalence, run by Poxel SA at 1 site in United Kingdom.
Trial summary
This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Imeglimin Reference product and Imeglimin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 2 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI : 18.5-29.9
- Body weight ≥ 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Who cannot join
- Positive tests for hepatitis B \& C, HIV
- severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies
- drug or alcohol abuse
- smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily
- over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol [acetaminophen] and oral contraception);
- participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months
Show all 14Show fewer
- vital signs outside the acceptable range
- clinically relevant abnormal findings at the screening assessment; estimated glomerular filtration rate (eGFR) at screening < 80 mL/min/1.73 m2
- acute or chronic illness
- clinically relevant abnormal medical history or concurrent medical condition;
- surgery or medical condition that might affect the absorption of medicines;
- possibility that volunteer will not cooperate
- pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception;
- objection by the volunteer's General Practitioner (GP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects
This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers.
- Conditions
- Bioequivalence
- Being tested
- Imeglimin Reference product, Imeglimin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imeglimin Reference productDrug
Reference product
ImegliminDrug
Test product (new formulation tablet)
| Study group | Role | What they receive |
|---|---|---|
| Tablet A in Session 1 and Tablet B in Session 2 | Experimental | Tablet A = reference product Tablet B = test product Receives: Drug: Imeglimin Reference product; Drug: Imeglimin |
| Tablet B in Session 1 and Tablet A in Session 2 | Experimental | Tablet A = reference product Tablet B = test product Receives: Drug: Imeglimin Reference product; Drug: Imeglimin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pk parameters of imeglimin
Cmax: peak plasma concentration after dosing
Measured: from dosing up to 48h
Secondary outcomes (2)
PK parameters of Imeglimin
AUC last: area Under the concentration time curve
Measured: from dosing up to 48h
Incidence of treatment emergent adverse events (Safety and tolerability)
Incidence of treatment emergent adverse events
Measured: From Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start3 Sep 2018
- Primary completion27 Sep 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646331
- Sponsor's protocol ID
- PXL008-022
- Status last verified
- Jan 2019
- First submitted
- 23 Aug 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03646331
- Acronym / sponsor ID
- PXL008-022
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet A in Session 1 and Tablet B in Session 2 | Experimental | Drug: Imeglimin Reference product, Drug: ImegliminTablet A = reference product Tablet B = test product |
| Tablet B in Session 1 and Tablet A in Session 2 | Experimental | Drug: Imeglimin Reference product, Drug: ImegliminTablet A = reference product Tablet B = test product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI : 18.5-29.9
- Body weight ≥ 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Key exclusion criteria (14 listed)
- Positive tests for hepatitis B \& C, HIV
- severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies
- drug or alcohol abuse
- smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily
- over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol [acetaminophen] and oral 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 |
|---|---|---|
| Imeglimin Reference productReference product | Drug | Tablet A in Session 1 and Tablet B in Session 2, Tablet B in Session 1 and Tablet A in Session 2 |
| ImegliminTest product (new formulation tablet) | Drug | Tablet A in Session 1 and Tablet B in Session 2, Tablet B in Session 1 and Tablet A in Session 2 |
Primary outcome
Pk parameters of imeglimin
Time frame: from dosing up to 48h
Cmax: peak plasma concentration after dosing
2 secondary outcomes
PK parameters of Imeglimin
Time frame: from dosing up to 48h
Incidence of treatment emergent adverse events (Safety and tolerability)
Time frame: From Day 1 to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Imeglimin Reference product and Imeglimin in people with Bioequivalence, run by Poxel SA at 1 site in United Kingdom.
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 14 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 11 Jan 2019. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pk parameters of imeglimin (time frame: from dosing up to 48h). 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 11 Jan 2019.