Bioequivalence Study of Idalopirdine in Healthy Subjects

Lundbeck

Status and phase: Withdrawn; Phase 1

Conditions: Bioequivalence

Treatments: Drug: Idalopirdine clinical tablet (reference); Drug: Idalopirdine commercial tablet (test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02894515

16976A

2016-000405-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women with a body mass index (BMI) of >18.5 and <30 kg/m2.

Exclusion criteria

• pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Test/Reference

Experimental group

Description:

Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days

Treatment:

Drug: Idalopirdine commercial tablet (test)

Drug: Idalopirdine clinical tablet (reference)

Reference/Test

Experimental group

Description:

Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days

Treatment:

Drug: Idalopirdine commercial tablet (test)

Drug: Idalopirdine clinical tablet (reference)