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

This study has been completed.

Sponsor:

Information provided by:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01005160

First received: October 28, 2009

Last updated: January 10, 2011

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2009

Last Updated Date

January 10, 2011

Start Date ^ICMJE

October 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CKD - 501 and metformin Pharmacokinetics evaluation [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01005160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CKD-501 and metformin safety evaluation [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Interaction Between CKD-501 and Metformin

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Healthy Male Volunteers

Intervention ^ICMJE

Drug: Metformin
CKD-501 0.5mg, metformin 1000mg

Other Name: Lobeglitazone
Drug: CKD-501
CKD-501 0.5mg, metformin 1000mg

Other Name: Lobeglitazone

Study Arm (s)

Experimental: CKD501

Interventions:

Drug: Metformin
Drug: CKD-501

Publications *

Shin D, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects. Curr Med Res Opin. 2012 Jul;28(7):1213-20. Epub 2012 Jul 2.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01005160

Other Study ID Numbers ^ICMJE

CKD-19HPS09H, 19HPS09H

Has Data Monitoring Committee

Responsible Party

Chin Kim, Chong Kun Dang

Study Sponsor ^ICMJE

Chong Kun Dang Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kyung S Yu

Seoul National University Hospital

Information Provided By

Chong Kun Dang Pharmaceutical

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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