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

October 19, 2018 updated by: Jae Yong Chung, MD, PhD, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rosuvastatin 20 mg PO
Rosuvastatin 20 mg daily for 21 days
Drug: Rosuvastatin
Open-label, one-sequence, multiple administration
Other Names:
  • Rosuvastatin 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
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
Time Frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
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)
Time Frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Pharmacodynamic evaluation
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
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
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Triglyceride in mg/dL)
Time Frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Pharmacodynamic evaluation
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
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
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid metabolites
Time Frame: Day -1 0 hour, Day 21 0 hour
Metabolites evaluation
Day -1 0 hour, Day 21 0 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Yong Chung, South Korea Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

October 19, 2018

First Posted (ACTUAL)

October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rosuvastatin_Elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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