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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: Rosuvastatin
    • Open-label, one-sequence, multiple administration

Arms, Groups and Cohorts

  • Experimental: Rosuvastatin 20 mg PO
    • Rosuvastatin 20 mg daily for 21 days

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 65 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jae Yong Chung, MD, PhD, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jae-Yong Chung, Principal Investigator, South Korea Seoul National University Bundang Hospital

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