CKD-391 Pharmacokinetic Study Phase I

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

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

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• Bwt >=50kg, BMI 18.5~25

• signed the informed consent form prior to the study participation

Exclusion Criteria:

• - Clinically significant disease

• Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug

• Clinically significant allergic disease

• Impossible to taking the institutional standard meal

• Previously donate whole blood within 60 days or component blood within 20 days

• Previously participated in other trial within 90 days

• Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials

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