A Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects

ConditionHealthy Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorDong-A ST Co., Ltd.

About this trial

This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 1 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization

Trial design

Design model

Crossover

Treatments tested in this trial

  • DA-5223-R

    Drug

    once a day

  • DA-5223-F

    Drug

    once a day

  • DA-5223-M

    Drug

    once a day

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions
Group C: Sequence CExperimental treatment 2 interventions
Group D: Sequence DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUClast

Area under the plasma concentration-time curve from time zero to time the last quantifiable time

Time frame
0~8 hours
2

Cmax

Peak Plasma Concentration

Time frame
0~8 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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