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A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05214690
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
26
Actual Duration (Days)
43.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers
Actual Study Start Date :
Aug 13, 2020
Actual Primary Completion Date :
Sep 8, 2020
Actual Study Completion Date :
Sep 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence A

cross-over

Drug: DW1809-T2
pelubiprofen 25mg
Other Names:
  • Test

    • Drug: DW1809-1
    pelubiprofen 30mg (PELUBI tab.)
    Other Names:
  • Reference

    		•
    Experimental: Sequence B

    cross-over

    Drug: DW1809-T2
    pelubiprofen 25mg
    Other Names:
  • Test

    • Drug: DW1809-1
    pelubiprofen 30mg (PELUBI tab.)
    Other Names:
  • Reference

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [up to 8 hour]

      Pharmacokinetics of Pelubiprofen

    2. Area under the plasma concentration versus time curve (AUC) [up to 8 hour]

      Pharmacokinetics of Pelubiprofen

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy 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

    • In the case of women, pregnant(Urine-HCG positive) or lactating women

    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:
    NCT05214690
    Other Study ID Numbers:
    • DW1809-102
    First Posted:
    Jan 31, 2022
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Jan 31, 2022