Diabetes Mellitus, Type 2, Osteoporosis
Conditions
Brief summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
Interventions
DRUGEvogliptin
10 mg
Sponsors
DongGuk University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactNamyi Gu, MD, PhD
Outcome results
None listed