Cilostazol-Simvastatin Drug Interaction Study

A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers

This is a randomized, open-label, single & multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male volunteers

Study Overview

• Status: Unknown
• Conditions: Dyslipidemias; Peripheral Artery Disease
• Intervention / Treatment: Drug: Simvastatin; Drug: Cilostazol; Drug: Pravastatin

Detailed Description

Eligibility for participation of this study will be 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 will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).

On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

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

Contacts and Locations

• Study Contact: Name: Doo-Yeoun Cho, MD; Phone Number: +82-31-219-4271; Email: dooycho@ajou.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Suwon, Gyeonggi, Korea, Republic of, 443-380
      • Recruiting
      • Ajou University Medical Center
      • Contact: Doo-Yeoun Cho, MD; Phone Number: +82-31-219-4271; Email: dooycho@ajou.ac.kr
      • Principal Investigator: Doo-Yeoun Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects aged 20 - 45 years
• With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
• Agreement with written informed consent

Exclusion Criteria:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
• Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
• Taking OTC(Over the counter)medicine including oriental medicine within 7 days
• Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
• Subject with known for hypersensitivity reaction to Cilostazol, Simvastatin or Pravastatin
• Previous whole blood donation within 60 days or component blood donation within 30 days
• Previous participation of other trial within 90 days
• Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simvastatin+Cilostazol; Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8.	Drug: Simvastatin; Simvastatin 40 mg on Day 1 & Day 8.; Other Names: S; Drug: Cilostazol; Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.; Other Names: C
Active Comparator: Pravastatin+Cilostazol; Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8.	Drug: Cilostazol; Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.; Other Names: C; Drug: Pravastatin; Pravastatin 20 mg on Day 1 & Day 8.; Other Names: P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC (area under the time-concentration curve) of Simvastatin	up to 12 hours after Simvastatin dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum plasma concentration) of Simvastatin	up to 12 hours after Simvastatin dosing
Cmax (maximum plasma concentration) of Pravastatin	up to 12 hours after Pravastatin dosing
AUC (area under the time-concentration curve) of Pravastatin	up to 12 hours after Pravastatin dosing

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interaction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Lipid Metabolism Disorders; Peripheral Vascular Diseases; Peripheral Arterial Disease; Dyslipidemias; 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; Pravastatin; Simvastatin; Cilostazol
• Other Study ID Numbers: DDI-103