- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02179931
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
September 3, 2014 updated by: H. Lundbeck A/S
Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
-
Leeds, United Kingdom, LS2 9LH
- Covance Clinical Research Unit
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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
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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: Flupentixol/melitracen film-coated tablet
test treatment - 0.5 mg/10 mg; oral as a single dose
|
|
Other: Flupentixol/melitracen coated tablet (Deanxit®)
reference treatment - 0.5 mg/10 mg, oral as a single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 72 hours post dose
|
Maximum observed concentration (Cmax) of flupentixol
Time Frame: Up to 312 hours post dose
|
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
|
Up to 72 hours post dose
|
Maximum observed concentration (Cmax) of melitracen
Time Frame: Up to 312 hours post dose
|
Up to 312 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
June 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
June 30, 2014
First Submitted That Met QC Criteria
June 30, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Estimate)
September 4, 2014
Last Update Submitted That Met QC Criteria
September 3, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15972A
- 2014-000431-17 (EudraCT Number)
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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