Effect of Evogliptin on Bone Metabolism in Human

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: DongGuk University

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.