Drug Interaction Between CKD-501 and Metformin (CKD-19HPS09H)

January 10, 2011 updated by: Chong Kun Dang Pharmaceutical

A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD501
Drug: Metformin
CKD-501 0.5mg, metformin 1000mg
Other Names:
  • Lobeglitazone
Drug: CKD-501
CKD-501 0.5mg, metformin 1000mg
Other Names:
  • Lobeglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CKD - 501 and metformin Pharmacokinetics evaluation
Time Frame: 16 days
16 days

Secondary Outcome Measures

Outcome Measure
Time Frame
CKD-501 and metformin safety evaluation
Time Frame: 16 days
16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Kyung S Yu, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKD-19HPS09H
  • 19HPS09H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Male Volunteers

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe