CKD-391 Pharmacokinetic Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Atrovastatin and Ezetimibe combination therapy
- Registration Number
- NCT02461004
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief 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.
- Detailed Description
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
Inclusion Criteria
- Bwt >=50kg, BMI 18~29
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description RT group Atrovastatin and Ezetimibe combination therapy combination dose of Atrovastatin and Ezetimibe and CKD-391 in order TR group CKD-391 CKD-391 and combination dose of Atrovastatin and Ezetimibe in order TR group Atrovastatin and Ezetimibe combination therapy CKD-391 and combination dose of Atrovastatin and Ezetimibe in order RT group CKD-391 combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
- Primary Outcome Measures
Name Time Method AUClast up to 96 hours post dose Cmax up to 96 hours post dose
- Secondary Outcome Measures
Name Time Method Adverse events up to 24days post dose Tmax up to 96 hours post dose T1/2 up to 96 hours post dose AUCinf up to 96 hours post dose
Trial Locations
- Locations (1)
The Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
The Korea University Anam Hospital🇰🇷Seoul, Korea, Republic of