A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly

Study Overview
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Brief Summary
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A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin

Official Title
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A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin

Conditions
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Elderly

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subjects aged 65 - 85 years A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2. Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations. Exclusion Criteria: Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor Subject judged not eligible for study participation by investigator

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 20 mg PO<br>Rosuvastatin 20 mg daily for 21 days | Drug: Rosuvastatin<br>* Open-label, one-sequence, multiple administration<br>* Other names: Rosuvastatin 20 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour | 
| Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour | 
| Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid panel (low-density lipoprotein cholesterol in mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour | 
| lipid panel (high-density lipoprotein cholesterol in mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour | 
| lipid panel (Triglyceride in mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour | 
| lipid panel (Total cholesterol in units of mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour | 
| lipid metabolites | Metabolites evaluation | Day -1 0 hour, Day 21 0 hour |