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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715101
• Other study ID #: Rosuvastatin_Elderly
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

Drug:
• Rosuvastatin
Open-label, one-sequence, multiple administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	lipid panel (low-density lipoprotein cholesterol in mg/dL)	Pharmacodynamic evaluation	Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Secondary	lipid panel (high-density lipoprotein cholesterol in mg/dL)	Pharmacodynamic evaluation	Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Secondary	lipid panel (Triglyceride in mg/dL)	Pharmacodynamic evaluation	Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Secondary	lipid panel (Total cholesterol in units of mg/dL)	Pharmacodynamic evaluation	Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
Secondary	lipid metabolites	Metabolites evaluation	Day -1 0 hour, Day 21 0 hour