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Study to Evaluate the Safety and PK Properties of DWP16001 in Healthy Subjects With Various Ethnicities

NCT05207176 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-01-26

No results posted yet for this study

Summary

An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics

Conditions

  • Healthy

Interventions

DRUG

DWP16001

Subjects should fast except for drinking water after 10 p.m. in order to maintain a fasting state for at least 10 hours before administration. On dosing days (5d to 10d), except for 1d and 11d, breakfast can be consumed from about 1 hour after administration of the clinical trial drug. Subjects should swallow the investigational drug whole with 150 mL of water, and should not chew the drug before swallowing. Subjects should fast for 4 hours after dosing, and can drink water freely from 2 hours after dosing.

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2022-04-08
Completion
2022-08-31

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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 NCT05207176 on ClinicalTrials.gov