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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5222-R2; Drug: DA-5222; Drug: DA-5222-R3; Drug: DA-5222-R1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07046715

DA5222_BEF_I

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-5222-R3

Drug: DA-5222-R1

Drug: DA-5222

Drug: DA-5222-R2

Sequence B

Experimental group

Treatment:

Drug: DA-5222-R3

Drug: DA-5222-R1

Drug: DA-5222

Drug: DA-5222-R2