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

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ClinicalTrials.gov Identifier: NCT03715101
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, MD, PhD, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Elderly Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rosuvastatin 20 mg PO
Rosuvastatin 20 mg daily for 21 days
Drug: Rosuvastatin
Open-label, one-sequence, multiple administration
Other Name: Rosuvastatin 20 mg




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 Outcome Measures :
  1. 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

  2. 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

  3. lipid panel (Triglyceride in mg/dL) [ Time Frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour ]
    Pharmacodynamic evaluation

  4. 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

  5. lipid metabolites [ Time Frame: Day -1 0 hour, Day 21 0 hour ]
    Metabolites evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715101


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jae-Yong Chung South Korea Seoul National University Bundang Hospital

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Responsible Party: Jae Yong Chung, MD, PhD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03715101     History of Changes
Other Study ID Numbers: Rosuvastatin_Elderly
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors