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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01005160
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:

October 28, 2009
October 30, 2009
January 12, 2011
October 2009
December 2009   (Final data collection date for primary outcome measure)
CKD - 501 and metformin Pharmacokinetics evaluation [ Time Frame: 16 days ]
Same as current
Complete list of historical versions of study NCT01005160 on ClinicalTrials.gov Archive Site
CKD-501 and metformin safety evaluation [ Time Frame: 16 days ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Between CKD-501 and Metformin
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Male Volunteers
  • Drug: Metformin
    CKD-501 0.5mg, metformin 1000mg
    Other Name: Lobeglitazone
  • Drug: CKD-501
    CKD-501 0.5mg, metformin 1000mg
    Other Name: Lobeglitazone
Experimental: CKD501
Interventions:
  • Drug: Metformin
  • Drug: CKD-501
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. doi: 10.1185/03007995.2012.703131. Epub 2012 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01005160
CKD-19HPS09H
19HPS09H
No
Not Provided
Not Provided
Chin Kim, Chong Kun Dang
Chong Kun Dang Pharmaceutical
Not Provided
Principal Investigator: Kyung S Yu Seoul National University Hospital
Chong Kun Dang Pharmaceutical
October 2009

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