Effect of Evogliptin on Bone Metabolism in Human
Study Details
Study Description
Brief Summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Evogliptin 10 mg Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL |
Drug: Evogliptin
10 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Postmenopausal healthy women (at least 5 years)
-
BMI 18~30 kg/m2
Exclusion Criteria:
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Presence or history of hypersensitivity or allergic reactions to any drug
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Clinically relevant abnormal medical history or present disease
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Presence or history of drug abuse
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Participation in other clinical trial within 2 months before dose.
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Bood donation during 2 months or apheresis during 1 month before the study.
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Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
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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.
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Smoking of more than 10 cigarettes/days within 3 months before first dose.
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Use of alcohol over 21 units/weeks
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Subject judged not eligible for study participation by investigator.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dongguk University Ilsan Hospital | Goyang | Gyeonggi | Korea, Republic of | 410-773 |
Sponsors and Collaborators
- DongGuk University
Investigators
- Principal Investigator: Namyi Gu, MD, PhD, Dongguk University College of Medicine and Ilsan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DUMC-EVOG-BONE