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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03715101

Enrollment

Registered

2018-10-22

Start date

2015-04-30

Completion date

2016-04-30

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly

Brief summary

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

Interventions

DRUGRosuvastatin

Open-label, one-sequence, multiple administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

65 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 (low-density lipoprotein cholesterol 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 (high-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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026