Effect of Evogliptin on Bone Metabolism in Human

DongGuk University

Status and phase: Unknown; Phase 4

Conditions: Osteoporosis; Diabetes Mellitus, Type 2

Treatments: Drug: Evogliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02587975

DUMC-EVOG-BONE

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Evogliptin 10 mg

Experimental group

Description:

Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL

Treatment:

Drug: Evogliptin