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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin 20 mg PO

Rosuvastatin 20 mg daily for 21 days

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Open-label, one-sequence, multiple administration

Interventions

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Rosuvastatin

Open-label, one-sequence, multiple administration

Intervention Type DRUG

Other Intervention Names

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Rosuvastatin 20 mg

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes