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

Seoul National University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Elderly

Interventions

RosuvastatinDRUG

Open-label, one-sequence, multiple administration

Eligibility

Sex: MALEMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin

Pharmacokinetic evaluation

Time frame: 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

Time frame: 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

Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour

Secondary Outcomes

lipid panel (low-density lipoprotein cholesterol in mg/dL)

Pharmacodynamic evaluation

Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

lipid panel (high-density lipoprotein cholesterol in mg/dL)

Pharmacodynamic evaluation

Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

lipid panel (Triglyceride in mg/dL)

Pharmacodynamic evaluation

Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

lipid panel (Total cholesterol in units of mg/dL)

Pharmacodynamic evaluation

Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

lipid metabolites

Data from ClinicalTrials.gov

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