Effect of Evogliptin on Bone Metabolism in Human
Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Jun 2016
Shorter than P25 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJuly 25, 2016
July 1, 2016
5 months
October 26, 2015
July 21, 2016
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (1)
Evogliptin 10 mg
EXPERIMENTALSingle oral administration of 2 tablets of evogliptin 5 mg with water 250 mL
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal healthy women (at least 5 years)
- BMI 18\~30 kg/m2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Namyi Gu, MD, PhD
Dongguk University College of Medicine and Ilsan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 27, 2015
Study Start
June 1, 2016
Primary Completion
November 1, 2016
Study Completion
March 1, 2017
Last Updated
July 25, 2016
Record last verified: 2016-07