HealthyPhase 1NCT03472651
Bioequivalence Study to Compare Two Formulations of Deanxit®
A Phase 1 study testing test treatment: flupentixol/melitracen and reference treatment: flupentixol/melitracen in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
Trial summary
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- test treatment: flupentixol/melitracen and reference treatment: flupentixol/melitracen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2018to 28 Jun 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
- Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2.
- Women must be non-pregnant and non-lactating
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition
- Conditions
- Healthy
- Being tested
- test treatment: flupentixol/melitracen, reference treatment: flupentixol/melitracen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test treatment: flupentixol/melitracenDrug
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
reference treatment: flupentixol/melitracenDrug
Also called Deanxit®
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 Fasted condition | Experimental | Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort Receives: Drug: test treatment: flupentixol/melitracen; Drug: reference treatment: flupentixol/melitracen |
| Cohort A2 Fed condition | Experimental | Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort Receives: Drug: test treatment: flupentixol/melitracen; Drug: reference treatment: flupentixol/melitracen |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72h: flupentixol
the area under the flupentixol plasma concentration-time curve
Measured: from zero to 72 hours post-dose
Cmax: flupentixol
maximum observed plasma concentration of flupentixol
Measured: from zero to 72 hours post-dose
AUC0-72h: melitracen
the area under the melitracen plasma concentration-time curve
Measured: from zero to 72 hours post-dose
Cmax: melitracen
maximum observed concentration of melitracen
Measured: from zero to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start7 May 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472651
- Sponsor's protocol ID
- 17686A
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2018
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions
- ClinicalTrials.gov ID
- NCT03472651
- Acronym / sponsor ID
- 17686A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 21 Mar 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.
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 Fasted condition | Experimental | Drug: test treatment: flupentixol/melitracen, Drug: reference treatment: flupentixol/melitracenSubjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort |
| Cohort A2 Fed condition | Experimental | Drug: test treatment: flupentixol/melitracen, Drug: reference treatment: flupentixol/melitracenSubjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2.
- Women must be non-pregnant and non-lactating
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| test treatment: flupentixol/melitracen0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose | Drug | Cohort A1 Fasted condition, Cohort A2 Fed condition |
| reference treatment: flupentixol/melitracenAlso: Deanxit®0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose | Drug | Cohort A1 Fasted condition, Cohort A2 Fed condition |
Primary outcome
AUC0-72h: flupentixol
Time frame: from zero to 72 hours post-dose
the area under the flupentixol plasma concentration-time curve
Cmax: flupentixol
Time frame: from zero to 72 hours post-dose
maximum observed plasma concentration of flupentixol
AUC0-72h: melitracen
Time frame: from zero to 72 hours post-dose
the area under the melitracen plasma concentration-time curve
Cmax: melitracen
Time frame: from zero to 72 hours post-dose
maximum observed concentration of melitracen
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 29 Feb 2024.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
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 test treatment: flupentixol/melitracen and reference treatment: flupentixol/melitracen in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
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 2 inclusion and 0 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 29 Feb 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 China. 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?
AUC0-72h: flupentixol (time frame: from zero to 72 hours post-dose). The study lists 4 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 29 Feb 2024.