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

NCT01744808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Normal, Healthy Volunteers

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2014-02-01
Completion
2014-02-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744808 on ClinicalTrials.gov