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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.
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
Conditions
Interventions
EB-1020 IR
Immediate release
EB-1020 SR1
sustained release
EB-1020 SR2
Sustained release
EB-1020 SR3
Sustained release
Placebo
Placebo formulation
Locations (1)
Nucleus Network Ltd.
Melbourne, Victoria, Australia