Drug Interaction Between CKD-501 and Metformin

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.

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Detailed Description

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Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.

In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.

Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.

Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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CKD501

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

CKD-501 0.5mg, metformin 1000mg

CKD-501

Intervention Type DRUG

CKD-501 0.5mg, metformin 1000mg

Interventions

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Metformin

CKD-501 0.5mg, metformin 1000mg

Intervention Type DRUG

CKD-501

CKD-501 0.5mg, metformin 1000mg

Intervention Type DRUG

Other Intervention Names

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Lobeglitazone Lobeglitazone

Eligibility Criteria

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Inclusion Criteria

* Between 20 aged and 45 aged in healthy males
* Weight more than 55kg, IBW 20% within the range
* FPG 70\~125 mg/dL
* Agreement with written informed consent

Exclusion Criteria

* Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
* Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
* Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
* AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
* systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
* Substance abuse, or a history of drug abuse showed a positive for the party
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Previously participated in other trial within 2 months
* Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
* Continued to be drunk or during clinical trials can not be drunk
* 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
* Containing grapefruit foods ingested during clinical trials or can not be ingested
* Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes