Effect of Evogliptin on Bone Metabolism in Human
- Registration Number
- NCT02587975
- Lead Sponsor
- DongGuk University
- Brief Summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evogliptin 10 mg Evogliptin Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dongguk University Ilsan Hospital
🇰🇷Goyang, Gyeonggi, Korea, Republic of