A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedOctober 22, 2018
October 1, 2018
1 year
July 19, 2017
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
lipid panel (low-density lipoprotein cholesterol in mg/dL)
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (high-density lipoprotein cholesterol in mg/dL)
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Triglyceride in mg/dL)
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Total cholesterol in units of mg/dL)
Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid metabolites
Day -1 0 hour, Day 21 0 hour
Study Arms (1)
Rosuvastatin 20 mg PO
EXPERIMENTALRosuvastatin 20 mg daily for 21 days
Interventions
Open-label, one-sequence, multiple administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Yong Chung
South Korea Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2017
First Posted
October 22, 2018
Study Start
April 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 22, 2018
Record last verified: 2018-10