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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Elderly

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03715101

Rosuvastatin_Elderly

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Rosuvastatin 20 mg PO

Experimental group

Description:

Rosuvastatin 20 mg daily for 21 days

Treatment:

Drug: Rosuvastatin