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

Healthy Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

1. Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study

2. Administration method:

The subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (DA-5215 or DA-5215-R) with 150 mL of water at around 8 a.m. on 1D of each period. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the 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,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times) ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05376085
• Study type: Interventional
• Source: Dong-A ST Co., Ltd.
• Contact: SeungHyun Kang, Ph.D
• Phone: 82-070-4665-9490
• Email: juspa@naver.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2022
• Completion date: July 2022