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Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT06147908
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
4.6
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Oct 26, 2022
Actual Study Completion Date :
Nov 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence A

cross-over

Drug: DW5221
megestrol acetate
Other Names:
  • Test

    • Drug: DW5221-R
    megestrol acetate
    Other Names:
  • Reference

    		•
    Experimental: Sequence B

    cross-over

    Drug: DW5221
    megestrol acetate
    Other Names:
  • Test

    • Drug: DW5221-R
    megestrol acetate
    Other Names:
  • Reference

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [up to 120 hour]

      Pharmacokinetics of Megestrol Acetate

    2. Area under the plasma concentration versus time curve (AUC) [up to 120 hour]

      Pharmacokinetics of Megestrol Acetate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungbuk National University Hospital Cheongju-si Korea, Republic of

    Sponsors and Collaborators

    • Daewon Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewon Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT06147908
    Other Study ID Numbers:
    • DW5221-1
    First Posted:
    Nov 28, 2023
    Last Update Posted:
    Nov 28, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 28, 2023