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Clinical Trials/NCT06147908
NCT06147908
Completed
Phase 1

A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers

Daewon Pharmaceutical Co., Ltd.1 site in 1 country54 target enrollmentJuly 1, 2022
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ConditionsApetite Stimulants
InterventionsDW5221DW5221-R
DrugsDW5221DW5221-R

Overview

Phase
Phase 1
Intervention
DW5221
Conditions
Apetite Stimulants
Sponsor
Daewon Pharmaceutical Co., Ltd.
Enrollment
54
Locations
1
Primary Endpoint
Peak Plasma Concentration (Cmax)
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
November 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy Male Volunteers who are ≥19 years old
  • •Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria

  • •Clinically significant Medical History

Arms & Interventions

Sequence A

cross-over

Intervention: DW5221

Sequence A

cross-over

Intervention: DW5221-R

Sequence B

cross-over

Intervention: DW5221

Sequence B

cross-over

Intervention: DW5221-R

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Time Frame: up to 120 hour

Pharmacokinetics of Megestrol Acetate

Area under the plasma concentration versus time curve (AUC)

Time Frame: up to 120 hour

Pharmacokinetics of Megestrol Acetate

Study Sites (1)

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