- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371707
Bioequivalence Study of Idalopirdine Tablets 60 mg
May 6, 2015 updated by: H. Lundbeck A/S
Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
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
- Covance
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy men and women
-≥18 and ≤55 years of age
- body mass index (BMI) of >18.5 and <30 kg/m2
Exclusion Criteria:
- Pregnant and lactating women
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: Idalopirdine 60 mg formulation A (test)
|
Tablet for oral use, single dose
Other Names:
|
Experimental: Idalopirdine 60 mg formulation B (reference)
|
Tablet for oral use, single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the idalopirdine plasma concentration-time curve
Time Frame: 0 to 72 hours post-dose
|
0 to 72 hours post-dose
|
maximum observed concentration (Cmax) of idalopirdine
Time Frame: 0 to 72 hours post-dose
|
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
March 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
February 20, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Estimate)
May 7, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 16052A
- 2014-001799-69 (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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