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Bioequivalence Study of Lu AF35700

NCT ID: NCT03394482

Last Updated: 2018-11-29

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-10-05

Brief Summary

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The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

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Detailed Description

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Conditions

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Healthy

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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Lu AF35700 5 mg clinical formulation

Group Type EXPERIMENTAL

Lu AF35700 5 mg clinical formulation

Intervention Type DRUG

Lu AF35700 tablets 5 mg oral single dose

Lu AF35700 5 mg commercial formulation

Group Type EXPERIMENTAL

Lu AF35700 5 mg commercial formulation

Intervention Type DRUG

Lu AF35700 tablets 5 mg oral single dose

Lu AF35700 10 mg clinical formulation

Group Type EXPERIMENTAL

Lu AF35700 10 mg clinical formulation

Intervention Type DRUG

Lu AF35700 tablets 10 mg oral single dose

Lu AF35700 10 mg commercial formulation

Group Type EXPERIMENTAL

Lu AF35700 10 mg commercial formulation

Intervention Type DRUG

Lu AF35700 tablets 10 mg oral single dose

Lu AF35700 20 mg clinical formulation

Group Type EXPERIMENTAL

Lu AF35700 20 mg clinical formulation

Intervention Type DRUG

Lu AF35700 tablets 20 mg oral single dose

Lu AF35700 20 mg commercial formulation

Group Type EXPERIMENTAL

Lu AF35700 20 mg commercial formulation

Intervention Type DRUG

Lu AF35700 tablets 20 mg oral single dose

Interventions

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Lu AF35700 5 mg clinical formulation

Lu AF35700 tablets 5 mg oral single dose

Intervention Type DRUG

Lu AF35700 5 mg commercial formulation

Lu AF35700 tablets 5 mg oral single dose

Intervention Type DRUG

Lu AF35700 10 mg clinical formulation

Lu AF35700 tablets 10 mg oral single dose

Intervention Type DRUG

Lu AF35700 10 mg commercial formulation

Lu AF35700 tablets 10 mg oral single dose

Intervention Type DRUG

Lu AF35700 20 mg clinical formulation

Lu AF35700 tablets 20 mg oral single dose

Intervention Type DRUG

Lu AF35700 20 mg commercial formulation

Lu AF35700 tablets 20 mg oral single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women aged ≥18 and ≤55 years
* Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion Criteria

* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
* The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
* The subject has previously been dosed with Lu AF35700
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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Covance

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017-001335-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17481A

Identifier Type: -

Identifier Source: org_study_id

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