A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: Diluted Intravenous DA-5217; Drug: Undiluted Intravenous DA-5217

Study type: Interventional

Funder types: Industry

Identifiers

NCT07027982

DA5217_UGIB_I

Details and patient eligibility

About

This study will evaluate the pharmacokinetics and safety of Diluted and Undiluted Intravenous DA-5217 in healthy adult subjects.

Enrollment: 32 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male or female, 19 years to 45 years
• Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
• The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.

Exclusion criteria

• The subjects with existing or previous conditions that may influence the pharmacokinetics of drugs
• The subjects hypersensitive to any of the Investigational Product components or other drug components
• The subjects with clinically significant active chronic conditions
• The subjects with a positive urine drug test result or a history of drug abuse or dependence.
• 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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32 participants in 2 patient groups

Sequence 1

Experimental group

Treatment:

Drug: Undiluted Intravenous DA-5217

Drug: Diluted Intravenous DA-5217

Sequence 2

Experimental group

Treatment:

Drug: Undiluted Intravenous DA-5217

Drug: Diluted Intravenous DA-5217