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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Collaborator: Severance Hospital
• Treatments: Amlodipine

Criteria

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