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Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorDong-A ST Co., Ltd.

About this trial

This study is to compare pharmacokinetics and safety profiles of DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Subjects with clinically significant medical history

Subjects with history of drug abuse or addicted

Subjects with allergy or drug hypersensitivity

Trial design

Design model

Crossover

Treatments tested in this trial

  • DA-5222

    Drug

    single dose administration (DA-5222 one tablet once a day)

  • DA-5222-R1

    Drug

    single dose administration (DA-5222-R1 one tablet once a day)

  • DA-5222-R2

    Drug

    single dose administration (DA-5222-R2 one tablet once a day)

  • DA-5222-R3

    Drug

    single dose administration (DA-5222-R3 one tablet once a day)

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Sequence AExperimental treatment 4 interventions
Group B: Sequence BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

AUCt

area under the curve

Time frame
pre-dose~72 hours post-dose
2

Cmax

maximum plasma concentration

Time frame
pre-dose~72 hours post-dose

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dong-A ST Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: