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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RG1662 tablet; Drug: RG1662 granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194244

WP28978

2014-001762-97 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 4 patient groups

Granules Fasted

Experimental group

Treatment:

Drug: RG1662 granules

Granules Fed

Experimental group

Treatment:

Drug: RG1662 granules

Tablet Fasted

Active Comparator group

Treatment:

Drug: RG1662 tablet

Tablet Fed

Active Comparator group

Treatment:

Drug: RG1662 tablet