Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5213 10mg; Drug: DA-5213-R 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05106205

BIBE2021-55

Details and patient eligibility

About

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteers
• BMI between 18.0 and 30.0 kg/m2
• Body weight : Male≥50kg, Female≥45kg

Exclusion criteria

• Allergy or Drug hypersensitivity
• Clinically significant Medical History

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-5213-R 10mg

Drug: DA-5213 10mg

Sequence B

Experimental group

Treatment:

Drug: DA-5213-R 10mg

Drug: DA-5213 10mg