Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Dong-A ST

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5221_01-R1 + DA-5221_01-R2; Drug: DA-5221_01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616883

DA5221_01_BE_I

Details and patient eligibility

About

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Enrollment: 44 estimated 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Experimental: Sequence A

Experimental group

Treatment:

Drug: DA-5221_01

Drug: DA-5221_01-R1 + DA-5221_01-R2

Experimental: Sequence B

Experimental group

Treatment:

Drug: DA-5221_01

Drug: DA-5221_01-R1 + DA-5221_01-R2