Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Dong-A ST

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5218; Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3

Study type: Interventional

Funder types: Industry

Identifiers

NCT05449704

DA5218_BE_I

Details and patient eligibility

About

Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers

Enrollment: 90 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 allergy or drug hypersensitivity
• 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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90 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-5218

Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3

Sequence B

Experimental group

Treatment:

Drug: DA-5218

Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3