Effect of Cilostazol on the Pharmacokinetics of Simvastatin

Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: simvastatin/cilostazol

Detailed Description

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects aged 20 - 48 years
• A body mass index (BMI) in the range 19-27 kg/m2
• Provide written informed consent after being fully informed about the study procedures
• Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
• Determined eligible in the ECG, clinical laboratory tests and urinalysis

Exclusion Criteria:

• Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
• Use of medication within 10 days before first dose
• Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
• Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
• Whole blood donation during 60 days before the study
• Participation in other clinical trial within 90 days prior to scheduled study drug administration
• Subject judged not eligible for study participation by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: simvastatin/cilostazol; simvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6	Drug: simvastatin/cilostazol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of simvastatin	Plasma concentration of simvastin on day 1 and day 6	7 days

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Inje University
• Investigators: Principal Investigator: JaeWook Ko, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Antimetabolites; Neuroprotective Agents; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Simvastatin; Cilostazol
• Other Study ID Numbers: 2011-04-070