A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy Adult

Treatments: Drug: DA-5223; Drug: DA-5223-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007533

DA5223_LSS_I

Details and patient eligibility

About

This study will compare and evaluate the safety, tolerability and pharmacokinetics between DA-5223 and DA-5223-R in healthy adult subjects

Enrollment: 38 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult male or female, 19 years to 55 years
• Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
• The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

Exclusion criteria

• The subjects with acute illness
• The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
• The subjects hypersensitive to any of the Investigational Product components or other drug components
• The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
• The subjects who are pregnant or lactating

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-5223-R

Drug: DA-5223

Sequence B

Experimental group

Treatment:

Drug: DA-5223-R

Drug: DA-5223