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Bioequivalence Study Between "DA-5215 Tab" and "DA-5215-R Tab"

NCT05376085 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-17

No results posted yet for this study

Summary

An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers

Conditions

  • Healthy

Interventions

DRUG

DA-5215 Tab

single oral administration of 1 tablet of "DA-5215 Tab" with 150mL water

DRUG

DA-5215-R Tab

single oral administration of 1 tablet of "DA-5215-R Tab" with 150mL water

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SeungHyun Kang, Ph.D · H Plus Yangji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-06-30
Completion
2022-07-31

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 NCT05376085 on ClinicalTrials.gov