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Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662

NCT ID: NCT02194244

Last Updated: 2016-11-02

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-08-31

Brief Summary

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This study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized, four-period, four-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Granules Fasted

Group Type EXPERIMENTAL

RG1662 granules

Intervention Type DRUG

Single dose, oral administration of RG1662 immediate release granules

Granules Fed

Group Type EXPERIMENTAL

RG1662 granules

Intervention Type DRUG

Single dose, oral administration of RG1662 immediate release granules

Tablet Fasted

Group Type ACTIVE_COMPARATOR

RG1662 tablet

Intervention Type DRUG

Single dose, oral administration of film-coated RG1662 immediate release tablet

Tablet Fed

Group Type ACTIVE_COMPARATOR

RG1662 tablet

Intervention Type DRUG

Single dose, oral administration of film-coated RG1662 immediate release tablet

Interventions

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RG1662 granules

Single dose, oral administration of RG1662 immediate release granules

Intervention Type DRUG

RG1662 tablet

Single dose, oral administration of film-coated RG1662 immediate release tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female volunteers, 18 to 60 years of age, inclusive

Exclusion Criteria

* A history of epilepsy, convulsions or significant head injury
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-001762-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP28978

Identifier Type: -

Identifier Source: org_study_id