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A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

NCT ID: NCT02167061

Last Updated: 2014-12-02

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\_01 in healthy male volunteers

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(Part 1) DA-1229_01 → E+M

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Group Type EXPERIMENTAL

DA-1229_01

Intervention Type DRUG

complex single administration

E+M

Intervention Type DRUG

co-administration of 2 drugs

(Part 1) E+M → DA-1229_01

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Group Type EXPERIMENTAL

DA-1229_01

Intervention Type DRUG

complex single administration

E+M

Intervention Type DRUG

co-administration of 2 drugs

(Part 2) DA-1229_01 fast → fed

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Group Type EXPERIMENTAL

DA-1229_01 fast

Intervention Type DRUG

DA-1229_01 fed

Intervention Type DRUG

DA-1229_01 fed → fast

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Group Type EXPERIMENTAL

DA-1229_01 fast

Intervention Type DRUG

DA-1229_01 fed

Intervention Type DRUG

Interventions

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DA-1229_01

complex single administration

Intervention Type DRUG

E+M

co-administration of 2 drugs

Intervention Type DRUG

DA-1229_01 fast

Intervention Type DRUG

DA-1229_01 fed

Intervention Type DRUG

Other Intervention Names

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Evogliptin/Metformin XR 5/1000 mg Evogliptin 5 mg + Metformin XR 1000 mg

Eligibility Criteria

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Inclusion Criteria

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 60-125mg/dL glucose level(at screening)
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-sang Yu, Ph.d., M.B.A

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Clinical Trial Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_01_BE_I

Identifier Type: -

Identifier Source: org_study_id