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OpenTrials
Completed

NCT Number: NCT02371707

Bioequivalence Study of Idalopirdine Tablets 60 mg

This study aims to establish bioequivalence between two tablet formulations of idalopirdine

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Idalopirdine 60 mg formulation A (test)

Drug

Tablet for oral use, single dose

Other names: Lu AE58054

Idalopirdine 60 mg formulation B (reference)

Drug

Tablet for oral use, single dose

Other names: Lu AE58054

Primary outcomes

  1. Area under the idalopirdine plasma concentration-time curve

    Time frame: 0 to 72 hours post-dose

  2. maximum observed concentration (Cmax) of idalopirdine

    Time frame: 0 to 72 hours post-dose

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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