Effect of Evogliptin on Bone Metabolism in Human

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evogliptin 10 mg

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

Group Type EXPERIMENTAL

Evogliptin

Intervention Type DRUG

10 mg

Interventions

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Evogliptin

10 mg

Intervention Type DRUG

Other Intervention Names

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DA-1229 Suganon

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes