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Bioequivalence Study of Idalopirdine in Healthy Subjects

NCT ID: NCT02894515

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test/Reference

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

Group Type EXPERIMENTAL

Idalopirdine commercial tablet (test)

Intervention Type DRUG

single dose, 10 mg, oral

Idalopirdine clinical tablet (reference)

Intervention Type DRUG

single dose, 10 mg, oral

Reference/Test

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

Group Type EXPERIMENTAL

Idalopirdine commercial tablet (test)

Intervention Type DRUG

single dose, 10 mg, oral

Idalopirdine clinical tablet (reference)

Intervention Type DRUG

single dose, 10 mg, oral

Interventions

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Idalopirdine commercial tablet (test)

single dose, 10 mg, oral

Intervention Type DRUG

Idalopirdine clinical tablet (reference)

single dose, 10 mg, oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB1050

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2016-000405-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16976A

Identifier Type: -

Identifier Source: org_study_id