Bioequivalence Study of Idalopirdine Tablets 60 mg

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Idalopirdine 60 mg formulation A (test); Drug: Idalopirdine 60 mg formulation B (reference)

• Registration Number: NCT02371707
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Study Start: 2015-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Idalopirdine 60 mg formulation A (test)	Idalopirdine 60 mg formulation A (test)	-
Idalopirdine 60 mg formulation B (reference)	Idalopirdine 60 mg formulation B (reference)	-

Primary Outcome Measures

Name	Time	Method
maximum observed concentration (Cmax) of idalopirdine	0 to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve	0 to 72 hours post-dose

Trial Locations

Locations (1)

Covance; 🇬🇧 Leeds, United Kingdom