Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State

Dong-A ST

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-1229_01-R; Drug: DA-1229_01

Study type: Interventional

Funder types: Industry

Identifiers

NCT07297940

DA1229_01-M_Fast_BE

Details and patient eligibility

About

This clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 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
• 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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40 participants in 2 patient groups

Sequence A

Experimental group

Treatment:

Drug: DA-1229_01

Drug: DA-1229_01-R

Sequence B

Experimental group

Treatment:

Drug: DA-1229_01

Drug: DA-1229_01-R