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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.

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

Details

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

Criteria

Inclusion Criteria:

• Between 20 aged and 45 years old in healthy males

• 18.5 ≤ IBW < 25

• Agreement with written informed consent

Exclusion Criteria:

• Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party

• Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial

• Subject has taken abnormal meals which affects the ADME of drug

• Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug

• 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

• Previously participated in other trial within 60 days

• Previously donate whole blood within 60 days or component blood within 30 days

• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug

• SBP >140 mmHg, SBP < 90 mmHg or DBP > 90 mmHg, DBP < 50 mmHg or Pulse > 100 per/min, Pulse < 50 per/min

• 12-lead ECG, QTc > 450 msec

• An impossible one who participates in clinical trial by investigator's decision including laboratory test result