Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

ConditionHealthy

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age19+

SponsorDong-A ST Co., Ltd.

About this trial

Pharmacokinetics and Safety Profiles After Administration of DA-5221\_01 and Co-administration of 5221\_01-R1 and DA-5221\_01-R2 in Healthy Adult Volunteers

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

Trial design

Design model

Crossover

Treatments tested in this trial

DA-5221_01
Drug
single dose administration (DA-5221\_01 one tablet once a day)
DA-5221_01-R1 + DA-5221_01-R2
Drug
single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Experimental: Sequence AExperimental treatment 2 interventions

Group B: Experimental: Sequence BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

AUCt

area under the curve

Time frame

pre-dose~72 hours post-dose

Cmax

maximum plasma concentration

Time frame

pre-dose~72 hours post-do

Sponsors and contacts

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

Dong-A ST Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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