To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects

Dong-A ST

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5222

Study type: Interventional

Funder types: Industry

Identifiers

NCT06993168

DA5222_FE_I

Details and patient eligibility

About

This study is to evaluate the effect of food on pharmacokinetics of DA-5222 in healthy adult subjects

Enrollment: 32 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
• Subjects with allergy or drug hypersensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-5222

Sequence B

Experimental group

Treatment:

Drug: DA-5222