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Clinical Trials/NCT05739851
NCT05739851Not yet recruitingPhase 1

An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

Dong-A ST Co., Ltd.1 site in 1 country40 target enrollmentStarted: March 18, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
Cmax
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg) at fasting state.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy Volunteers
  • •BMI between 18 and 30 kg/m2
  • •Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria

  • •Allergy or Drug hypersensitivity
  • •Clinically significant Medical History

Arms & Interventions

Sequence A(Before→ After)

Experimental

Intervention: DA-1229_01 2.5/500mg (Before) (Drug)

Sequence A(Before→ After)

Experimental

Intervention: DA-1229_01 2.5/500mg (After) (Drug)

Sequence B(After→ Before)

Experimental

Intervention: DA-1229_01 2.5/500mg (Before) (Drug)

Sequence B(After→ Before)

Experimental

Intervention: DA-1229_01 2.5/500mg (After) (Drug)

Outcomes

Primary Outcomes

Cmax

Time Frame: pre-dose~96 hours post-dose

maximum plasma concentration

AUCt

Time Frame: pre-dose~96 hours post-dose

area under the curve

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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