Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

Dong-A ST

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-1229_01 2.5/500mg (Before); Drug: DA-1229_01 2.5/500mg (After)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05739851

22-4247-BE022

Details and patient eligibility

About

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg) at fasting state.

Enrollment: 40 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

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(Before→ After)

Experimental group

Treatment:

Drug: DA-1229_01 2.5/500mg (Before)

Drug: DA-1229_01 2.5/500mg (After)

Sequence B(After→ Before)

Experimental group

Treatment:

Drug: DA-1229_01 2.5/500mg (Before)

Drug: DA-1229_01 2.5/500mg (After)