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Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

NCT ID: NCT01941199

Last Updated: 2013-11-27

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration 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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D → M → D+M

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

D → D+M → M

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

M → D → D+M

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

M → D+M → D

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

D+M → M → D

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

D+M → D → M

D : DA-1229 5mg qd, M : metformin 1000mg bid

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

Interventions

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DA-1229

Intervention Type DRUG

metformin

Intervention Type DRUG

DA-1229 + metformin

Intervention Type DRUG

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 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

* Subject 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)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Subject 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 in 1 months currently.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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_DIM_I

Identifier Type: -

Identifier Source: org_study_id