NCT05376085

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Detailed 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)

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-06-01
• Completion: 2022-07-01
• First posted: 2022-05-17
• Last updated: 2022-05-17

Locations

1 site across 1 country: South Korea