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DW0919-1003: Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01606059
Collaborator
Chungnam National University Hospital (Other)
30
Enrollment
1
Location
2
Arms
1
Duration (Months)
29.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DW-0919

Drug: DW-0919
Dosage form: Extended release tablet Dosage: 1 tablet
Other Names:
  • Acetaminophen: 650mg
  • Tramadol: 75mg

    		•
    Experimental: DW-0920

    Drug: DW-0920
    Dosage form: Extended release tablet Dosage: 2 tablets
    Other Names:
  • Acetaminophen: 325mg
  • Tramadol: 37.5mg
  • Wontran ER tab.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC of DW-0919(Acetaminophen, Tramadol) [0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36]

    2. Cmax of DW-0919(Acetaminophen, Tramadol) [0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36]

    3. AUC of DW-0920(Acetaminophen, Tramadol) [0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36]

    4. Cmax of DW-0920(Acetaminophen, Tramadol) [0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult males aged 20 to 55 years at screening.

    • No significant congenital/chronic disease.

    • No symptoms in physical examination.

    • Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.

    • Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

    Exclusion Criteria:

    • History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.

    • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.

    • History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungnam National University Hospital DaeJeon Korea, Republic of

    Sponsors and Collaborators

    • Daewon Pharmaceutical Co., Ltd.
    • Chungnam National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewon Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01606059
    Other Study ID Numbers:
    • DW0919-1003
    First Posted:
    May 25, 2012
    Last Update Posted:
    Oct 12, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Acetaminophen
    Tramadol

    Study Results

    No Results Posted as of Oct 12, 2016