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

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)
Drug: Idalopirdine 60 mg formulation A (test)
Tablet for oral use, single dose
Other Names:
  • Lu AE58054
Experimental: Idalopirdine 60 mg formulation B (reference)
Drug: Idalopirdine 60 mg formulation B (reference)
Tablet for oral use, single dose
Other Names:
  • Lu AE58054

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

H. Lundbeck A/S

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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