- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660840
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
July 25, 2016 updated by: H. Lundbeck A/S
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)
- Drug: 0.5 mg Flupentixol coated tablet (reference treatment)
- Drug: 1 mg Flupentixol film-coated tablet (test treatment)
- Drug: 1 mg Flupentixol coated tablet (reference treatment)
- Drug: 5 mg Flupentixol film-coated tablet (test treatment)
- Drug: 5 mg Flupentixol coated tablet (reference treatment)
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 Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Moscow, Russian Federation
- RU801
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.5 mg Test, then 0.5 mg reference
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
Experimental: 0.5 mg reference, then 0.5 mg Test
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
Experimental: 1 mg Test, then 1 mg reference
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
Experimental: 1 mg reference, then 1 mg Test
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
Experimental: 5 mg Test, then 5 mg reference
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
Experimental: 5 mg reference, then 5 mg Test
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)
|
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The area under the plasma concentration-time curve
Time Frame: from 0 to 72 hours post-dose
|
from 0 to 72 hours post-dose
|
The maximum observed concentration (Cmax)
Time Frame: from 0 to 72 hours post-dose
|
from 0 to 72 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
January 19, 2016
First Submitted That Met QC Criteria
January 20, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15969A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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