Drug-drug Interaction Study(CKD-501, Amlodipine)

A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers

The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Inclusion Criteria:

• Between 20 aged and 45 years old in healthy males
• Body weight ≥ 55kg and 18.5 ≤ IBW < 25
• Agreement with written informed consent

Exclusion Criteria:

• Subject has a history affects the ADME of drug
• Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
• AST,ALT > UNL * 1.25 or Total bilirubin > UNL * 1.5
• Estimated GFR(MDRD) < 80
• SBP >150 mmHg, SBP < 100 mmHg or DBP > 100 mmHg, DBP < 60 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
• Substance abuse, or a history of drug abuse showed a positive for the party
• Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
• Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
• Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
• Subject takes grapefruit within 1 month
• Previously participated in other trial within 60 days
• Previously donate whole blood within 60 days or component blood within 30 days
• An impossible one who participates in clinical trial by investigator's decision including laboratory test result