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

Phase 1

Completed

• Conditions: Elderly
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT03715101
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2017-07-19
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 20 mg PO	Rosuvastatin	Rosuvastatin 20 mg daily for 21 days

Primary Outcome Measures

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

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