Healthy Men and WomenPhase 1NCT02179931

Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

A Phase 1 study testing Flupentixol/melitracen film-coated tablet and Flupentixol/melitracen coated tablet (Deanxit®) in people with Healthy Men and Women, run by H. Lundbeck A/S at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Men and Women
What is being tested?: Flupentixol/melitracen film-coated tablet and Flupentixol/melitracen coated tablet (Deanxit®)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: Jun 2014to Jul 2014
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 <30 kg/m2.
Women will be non-pregnant and non-lactating.
Other protocol-defined inclusion and exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

Conditions: Healthy Men and Women
Being tested: Flupentixol/melitracen film-coated tablet, Flupentixol/melitracen coated tablet (Deanxit®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flupentixol/melitracen film-coated tabletDrug
Flupentixol/melitracen coated tablet (Deanxit®)Drug

Study groups in NCT02179931
Study group	Role	What they receive
Flupentixol/melitracen film-coated tablet	Experimental	test treatment - 0.5 mg/10 mg; oral as a single dose Receives: Drug: Flupentixol/melitracen film-coated tablet
Flupentixol/melitracen coated tablet (Deanxit®)	Other	reference treatment - 0.5 mg/10 mg, oral as a single dose Receives: Drug: Flupentixol/melitracen coated tablet (Deanxit®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
Measured: Up to 72 hours post dose
Maximum observed concentration (Cmax) of flupentixol
Measured: Up to 312 hours post dose
Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
Measured: Up to 72 hours post dose
Maximum observed concentration (Cmax) of melitracen
Measured: Up to 312 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jul 2014

First posted2 Jul 2014 (estimated)
Study startJun 2014
Primary completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Men and WomenStudies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02179931
Sponsor's protocol ID: 15972A
Other IDs: 2014-000431-17, 2014
Status last verified: Sep 2014
First submitted: 30 Jun 2014
Last updated: 4 Sep 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
ClinicalTrials.gov ID: NCT02179931
Acronym / sponsor ID: 15972A
Conditions: Healthy Men and Women
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jul 2014 (actual)
First posted: 2 Jul 2014 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Flupentixol/melitracen film-coated tablet	Experimental	Drug: Flupentixol/melitracen film-coated tablettest treatment - 0.5 mg/10 mg; oral as a single dose
Flupentixol/melitracen coated tablet (Deanxit®)	Other	Drug: Flupentixol/melitracen coated tablet (Deanxit®)reference treatment - 0.5 mg/10 mg, oral as a single dose

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of >18.5 and <30 kg/m2.
Women will be non-pregnant and non-lactating.
Other protocol-defined inclusion and exclusion criteria may apply.

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
Flupentixol/melitracen film-coated tablet	Drug	Flupentixol/melitracen film-coated tablet
Flupentixol/melitracen coated tablet (Deanxit®)	Drug	Flupentixol/melitracen coated tablet (Deanxit®)

Primary outcome

Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
Time frame: Up to 72 hours post dose
Maximum observed concentration (Cmax) of flupentixol
Time frame: Up to 312 hours post dose
Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)
Time frame: Up to 72 hours post dose
Maximum observed concentration (Cmax) of melitracen
Time frame: Up to 312 hours post dose

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 4 Sep 2014.

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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?

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 3 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 4 Sep 2014. 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?

Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) (time frame: Up 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?

On the ClinicalTrials.gov record for NCT02179931.

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 4 Sep 2014.