Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects in Fed State

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: DA-5222; Drug: DA-5222-R1; Drug: DA-5222-R2; Drug: DA-5222-R3

• Registration Number: NCT07046715
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This study is to compare pharmacokinetics and safety profiles of single-administration of DA-5222 and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects in fed state

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-08-01
• Primary Completion: 2025-08
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy volunteers
• BMI between 18 and 30 kg/m2
• Body weight: Male≥50kg, Female≥45kg
• Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria

• Subjects with clinically significant medical history
• Subjects with history of drug abuse or addicted
• Subjects with allergy or drug hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DA-5222	-
Sequence A	DA-5222-R1	-
Sequence A	DA-5222-R2	-
Sequence A	DA-5222-R3	-
Sequence B	DA-5222	-
Sequence B	DA-5222-R1	-
Sequence B	DA-5222-R2	-
Sequence B	DA-5222-R3	-

Primary Outcome Measures

Name	Time	Method
AUCt	pre-dose~48 hours post-dose	Area Under the Curve
Cmax	pre-dose~48 hours post-dose	Maximum Plasma Concentration