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COMPLETED
NCT01744808
PHASE1

A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.

Official title: A Phase 1 Study To Investigate the Pharmacokinetics of SR Formulations; and the Food Effect, Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020 In Young Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2013-02-01

Completion Date

2014-02-01

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

DRUG

EB-1020 IR

Immediate release

DRUG

EB-1020 SR1

sustained release

DRUG

EB-1020 SR2

Sustained release

DRUG

EB-1020 SR3

Sustained release

OTHER

Placebo

Placebo formulation

Locations (1)

Nucleus Network Ltd.

Melbourne, Victoria, Australia