Bioequivalence Study in Healthy SubjectsPhase 1NCT02660840
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
A Phase 1 study testing 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment) and 5 mg Flupentixol film-coated tablet (test treatment) in people with Bioequivalence Study in Healthy Subjects, run by H. Lundbeck A/S at 1 site in Russia.
Trial summary
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment) and 5 mg Flupentixol film-coated tablet (test treatment)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2016to Jun 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) of ≥18.5 and ≤30 kg/m2
- The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
Who cannot join
- The subject is pregnant or breastfeeding.
- The subject has taken any investigational medicinal products 3 months prior to the first dose
- The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids).
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
Read the detailed description
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
- Conditions
- Bioequivalence Study in Healthy Subjects
- Being tested
- 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment), 5 mg Flupentixol film-coated tablet (test treatment), 0.5 mg Flupentixol coated tablet (reference treatment), 1 mg Flupentixol coated tablet (reference treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg Flupentixol film-coated tablet (test treatment)Drug
single oral dose, fasted state, day 1 in period 1 or 2
1 mg Flupentixol film-coated tablet (test treatment)Drug
single oral dose, fasted state, day 1 in period 1 or 2
5 mg Flupentixol film-coated tablet (test treatment)Drug
single oral dose, fasted state, day 1 in period 1 or 2
0.5 mg Flupentixol coated tablet (reference treatment)Drug
Also called Fluanxol®
single oral dose, fasted state, day 1 in period 1 or 2
1 mg Flupentixol coated tablet (reference treatment)Drug
Also called Fluanxol®
single oral dose, fasted state, day 1 in period 1 or 2
5 mg Flupentixol coated tablet (reference treatment)Drug
Also called Fluanxol®
single oral dose, fasted state, day 1 in period 1 or 2
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg Test, then 0.5 mg reference | Experimental | 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference) Receives: Drug: 0.5 mg Flupentixol film-coated tablet (test treatment); Drug: 0.5 mg Flupentixol coated tablet (reference treatment) |
| 0.5 mg reference, then 0.5 mg Test | Experimental | 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test) Receives: Drug: 0.5 mg Flupentixol film-coated tablet (test treatment); Drug: 0.5 mg Flupentixol coated tablet (reference treatment) |
| 1 mg Test, then 1 mg reference | Experimental | 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference) Receives: Drug: 1 mg Flupentixol film-coated tablet (test treatment); Drug: 1 mg Flupentixol coated tablet (reference treatment) |
| 1 mg reference, then 1 mg Test | Experimental | 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test) Receives: Drug: 1 mg Flupentixol film-coated tablet (test treatment); Drug: 1 mg Flupentixol coated tablet (reference treatment) |
| 5 mg Test, then 5 mg reference | Experimental | 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference) Receives: Drug: 5 mg Flupentixol film-coated tablet (test treatment); Drug: 5 mg Flupentixol coated tablet (reference treatment) |
| 5 mg reference, then 5 mg Test | Experimental | 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) Receives: Drug: 5 mg Flupentixol film-coated tablet (test treatment); Drug: 5 mg Flupentixol coated tablet (reference treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve
Measured: from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
Measured: from 0 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 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies 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
- 84 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
- NCT02660840
- Sponsor's protocol ID
- 15969A
- Status last verified
- Jul 2016
- First submitted
- 19 Jan 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02660840
- Acronym / sponsor ID
- 15969A
- Conditions
- Bioequivalence Study in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- First posted
- 21 Jan 2016 (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.
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
Detailed description
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg Test, then 0.5 mg reference | Experimental | Drug: 0.5 mg Flupentixol film-coated tablet (test treatment), Drug: 0.5 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference) |
| 0.5 mg reference, then 0.5 mg Test | Experimental | Drug: 0.5 mg Flupentixol film-coated tablet (test treatment), Drug: 0.5 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test) |
| 1 mg Test, then 1 mg reference | Experimental | Drug: 1 mg Flupentixol film-coated tablet (test treatment), Drug: 1 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference) |
| 1 mg reference, then 1 mg Test | Experimental | Drug: 1 mg Flupentixol film-coated tablet (test treatment), Drug: 1 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test) |
| 5 mg Test, then 5 mg reference | Experimental | Drug: 5 mg Flupentixol film-coated tablet (test treatment), Drug: 5 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference) |
| 5 mg reference, then 5 mg Test | Experimental | Drug: 5 mg Flupentixol film-coated tablet (test treatment), Drug: 5 mg Flupentixol coated tablet (reference treatment)14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index (BMI) of ≥18.5 and ≤30 kg/m2
- The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (4 listed)
- The subject is pregnant or breastfeeding.
- The subject has taken any investigational medicinal products 3 months prior to the first dose
- The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids).
- Other protocol defined inclusion and exclusion criteria may apply
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 |
|---|---|---|
| 0.5 mg Flupentixol film-coated tablet (test treatment)single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 0.5 mg Test, then 0.5 mg reference, 0.5 mg reference, then 0.5 mg Test |
| 1 mg Flupentixol film-coated tablet (test treatment)single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 1 mg Test, then 1 mg reference, 1 mg reference, then 1 mg Test |
| 5 mg Flupentixol film-coated tablet (test treatment)single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 5 mg Test, then 5 mg reference, 5 mg reference, then 5 mg Test |
| 0.5 mg Flupentixol coated tablet (reference treatment)Also: Fluanxol®single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 0.5 mg Test, then 0.5 mg reference, 0.5 mg reference, then 0.5 mg Test |
| 1 mg Flupentixol coated tablet (reference treatment)Also: Fluanxol®single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 1 mg Test, then 1 mg reference, 1 mg reference, then 1 mg Test |
| 5 mg Flupentixol coated tablet (reference treatment)Also: Fluanxol®single oral dose, fasted state, day 1 in period 1 or 2 | Drug | 5 mg Test, then 5 mg reference, 5 mg reference, then 5 mg Test |
Primary outcome
The area under the plasma concentration-time curve
Time frame: from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
Time frame: from 0 to 72 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 26 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment) and 5 mg Flupentixol film-coated tablet (test treatment) in people with Bioequivalence Study in Healthy Subjects, run by H. Lundbeck A/S at 1 site in Russia.
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 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 26 Jul 2016. 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 Russia. 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?
The area under the plasma concentration-time curve (time frame: from 0 to 72 hours post-dose). 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 26 Jul 2016.