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Effect of Evogliptin on Bone Metabolism in Human

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ClinicalTrials.gov Identifier: NCT02587975
Recruitment Status : Unknown
Verified July 2016 by Namyi Gu, DongGuk University.
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Namyi Gu, DongGuk University

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Osteoporosis Drug: Evogliptin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : June 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : March 2017

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587975


Contacts
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Contact: Namyi Gu, MD, PhD +82-31-961-8440 namyi.gu@gmail.com

Locations
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Korea, Republic of
Dongguk University Ilsan Hospital Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-773
Contact: Namyi Gu, MD, PhD    +82-31-961-8440    namyi.gu@gmail.com   
Sponsors and Collaborators
DongGuk University
Investigators
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Principal Investigator: Namyi Gu, MD, PhD Dongguk University College of Medicine and Ilsan Hospital

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Responsible Party: Namyi Gu, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier: NCT02587975     History of Changes
Other Study ID Numbers: DUMC-EVOG-BONE
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Osteoporosis
Diabetes Mellitus, Type 2
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases