- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472651
Bioequivalence Study to Compare Two Formulations of Deanxit®
February 28, 2024 updated by: H. Lundbeck A/S
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Beijing, China
- CN1036 Shijitan Hospital
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
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: Cohort A1 Fasted condition
Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort
|
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Other Names:
|
Experimental: Cohort A2 Fed condition
Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort
|
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-72h: flupentixol
Time Frame: from zero to 72 hours post-dose
|
the area under the flupentixol plasma concentration-time curve
|
from zero to 72 hours post-dose
|
Cmax: flupentixol
Time Frame: from zero to 72 hours post-dose
|
maximum observed plasma concentration of flupentixol
|
from zero to 72 hours post-dose
|
AUC0-72h: melitracen
Time Frame: from zero to 72 hours post-dose
|
the area under the melitracen plasma concentration-time curve
|
from zero to 72 hours post-dose
|
Cmax: melitracen
Time Frame: from zero to 72 hours post-dose
|
maximum observed concentration of melitracen
|
from zero to 72 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
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 (Actual)
May 7, 2018
Primary Completion (Actual)
June 28, 2018
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
March 14, 2018
First Posted (Actual)
March 21, 2018
Study Record Updates
Last Update Posted (Actual)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17686A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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