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A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

NCT02622685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-06-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.

Conditions

  • Healthy

Interventions

DRUG

DWP10292

Drug: DWP10292 tablets, oral administration, multiple administration

DRUG

DWP10292 Placebo

Placebo tablets, oral administration, multiple administrations

DRUG

Ursodeoxycholic acid (UDCA)

Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration

DRUG

UDCA Placebo

Placebo tablets, oral administration, multiple administrations

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

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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 NCT02622685 on ClinicalTrials.gov