NCT04671316

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Detailed description

1. Study design: An open-Label, randomized, 6-sequence, 3-period, fasting condition, single-dose, per oral, cross-over study 2. Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (DA-5209 60mg) without water or (DA-5209 60mg or Lixiana 60mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time. 3. Wash out period: at least 7 days 4. Blood collection time: Before the administration, 5, 10, 15, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hr after the administration (total 15 times) 5. Analysis: Measurement of the concentration of an unchangeable substance of Edoxaban in plasma

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-23
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2020-12-17
• Last updated: 2021-02-09

Locations

1 site across 1 country: South Korea