Bioequivalence Study of Idalopirdine Tablets 60 mg

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Idalopirdine 60 mg formulation A (test); Drug: Idalopirdine 60 mg formulation B (reference)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371707

16052A

2014-001799-69 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Idalopirdine 60 mg formulation A (test)

Experimental group

Treatment:

Drug: Idalopirdine 60 mg formulation A (test)

Idalopirdine 60 mg formulation B (reference)

Experimental group

Treatment:

Drug: Idalopirdine 60 mg formulation B (reference)