Effect of Evogliptin on Bone Metabolism in Human

July 21, 2016 updated by: Namyi Gu, DongGuk University

Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-773
        • Recruiting
        • DongGuk University ilsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Suganon
  • DA-1229

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
Time Frame: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUMC-EVOG-BONE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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