A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers

ConditionHealthy Adult Volunteer

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age19-50

SponsorDaewon Pharmaceutical Co., Ltd.

About this trial

Safety and pharmacokinetic characteristics evaluation of DW4421-T1 and DW4421S-T1

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult aged 19 to 50 (inclusive) years

Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)

Disqualifiers

clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

Trial design

Design model

Crossover

Treatments tested in this trial

DW4421-T1
Drug
DW4421-T1 or DW4421S-T1
DW4421S-T1
Drug
DW4421-T1 or DW4421S-T1

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Sequence AExperimental treatment 2 interventions

Group B: Sequence BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Cmax

Time frame

up to 48 hour

AUC0-t

Time frame

up to 48 hour

Sponsors and contacts

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

Daewon Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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