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Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"

NCT04671316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-02-09

No results posted yet for this study

Summary

An Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" in Healthy Volunteers

Conditions

  • Healthy

Interventions

DRUG

DA-5209 60mg Tab

single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water

DRUG

DA-5209 60mg Tab

single oral administration of 1 tablet of "DA-5209 60mg Tab" without water

DRUG

Lixiana 60mg Tab

single oral administration of 1 tablet of "Lixiana 60mg 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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2021-02-04
Completion
2021-02-04

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 NCT04671316 on ClinicalTrials.gov