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”

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 Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: CKD501

Primary Measures

• CKD - 501 and metformin Pharmacokinetics evaluation
  • Time Frame: 16 days
    Safety Issue?: No

Secondary Measures

• CKD-501 and metformin safety evaluation
  • Time Frame: 16 days
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Chong Kun Dang Pharmaceutical

Overall Clinical Trial Officials and Contacts

Kyung S Yu Principal Investigator Seoul National University Hospital  

Overall Contact: Mi L Chung 82-2-2194-0462 irine3@ckdpharm.com

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01005160

Study ID Number: CKD-19HPS09H

ClinicalTrials.gov Identifier: NCT01005160

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)