Effect of Evogliptin on Bone Metabolism in Human

Sponsor
DongGuk University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02587975
Collaborator
(none)
20
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Study Details

Study Description

Brief Summary

This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Evogliptin 10 mg

Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL

Drug: Evogliptin
10 mg
Other Names:
  • DA-1229
  • Suganon
  • Outcome Measures

    Primary Outcome Measures

    1. Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline [Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Postmenopausal healthy women (at least 5 years)

    • BMI 18~30 kg/m2

    Exclusion Criteria:
    • Presence or history of hypersensitivity or allergic reactions to any drug

    • Clinically relevant abnormal medical history or present disease

    • Presence or history of drug abuse

    • Participation in other clinical trial within 2 months before dose.

    • Bood donation during 2 months or apheresis during 1 month before the study.

    • Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.

    • Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.

    • Smoking of more than 10 cigarettes/days within 3 months before first dose.

    • Use of alcohol over 21 units/weeks

    • Subject judged not eligible for study participation by investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongguk University Ilsan Hospital Goyang Gyeonggi Korea, Republic of 410-773

    Sponsors and Collaborators

    • DongGuk University

    Investigators

    • Principal Investigator: Namyi Gu, MD, PhD, Dongguk University College of Medicine and Ilsan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Namyi Gu, Assistant professor, DongGuk University
    ClinicalTrials.gov Identifier:
    NCT02587975
    Other Study ID Numbers:
    • DUMC-EVOG-BONE
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Jul 25, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 25, 2016