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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:
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Metformin Drug: CKD-501 Phase 1

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : October 2009
Primary Completion Date : December 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CKD501 Drug: Metformin
CKD-501 0.5mg, metformin 1000mg
Other Name: Lobeglitazone
Drug: CKD-501
CKD-501 0.5mg, metformin 1000mg
Other Name: Lobeglitazone



Primary Outcome Measures :
  1. CKD - 501 and metformin Pharmacokinetics evaluation [ Time Frame: 16 days ]

Secondary Outcome Measures :
  1. CKD-501 and metformin safety evaluation [ Time Frame: 16 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005160


Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Kyung S Yu Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chin Kim, Chong Kun Dang
ClinicalTrials.gov Identifier: NCT01005160     History of Changes
Other Study ID Numbers: CKD-19HPS09H
19HPS09H
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: October 2009

Keywords provided by Chong Kun Dang Pharmaceutical:
Mellitus, type 2
pharmacokinetic evaluation
drug interaction between CKD-501 and metformin

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs