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The Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects

NCT04686825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-05-26

No results posted yet for this study

Summary

This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects

Conditions

  • Healthy

Interventions

DRUG

DA-8010 2.5mg (Fasting)

Test drug l : DA-8010 2.5mg (Fasting)

DRUG

DA-8010 2.5mg (Fed)

Test drug ll : DA-8010 2.5mg (Fed)

DRUG

DA-8010 5mg (Fasting)

Test drug llI : DA-8010 5mg (Fasting)

DRUG

DA-8010 5mg (Fed)

Test drug lV : DA-8010 5mg (Fed)

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seung Hwan Lee, PhD · SNUH Clinical Pharmacololgy and Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2021-02-17
Completion
2021-03-11

Countries

  • South Korea

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 NCT04686825 on ClinicalTrials.gov