Cilostazol-Simvastatin Drug Interaction Study

NCT ID: NCT02431013

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

Brief Summary

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

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.

Conditions

Dyslipidemias; Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

Simvastatin 40 mg on Day 1 \& Day 8.

Cilostazol

Intervention Type: DRUG

Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.

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.

Group Type: ACTIVE_COMPARATOR

Pravastatin

Intervention Type: DRUG

Pravastatin 20 mg on Day 1 \& Day 8.

Cilostazol

Intervention Type: DRUG

Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.

Interventions

Simvastatin

Simvastatin 40 mg on Day 1 \& Day 8.

Intervention Type: DRUG

Pravastatin

Pravastatin 20 mg on Day 1 \& Day 8.

Intervention Type: DRUG

Cilostazol

Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.

Intervention Type: DRUG

Other Intervention Names

S; P; C

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Doo-Yeoun Cho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doo-Yeoun Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Doo-Yeoun Cho, MD

Role: CONTACT

dooycho@ajou.ac.kr

+82-31-219-4271

Facility Contacts

Doo-Yeoun Cho, MD

Role: primary

dooycho@ajou.ac.kr

+82-31-219-4271

Other Identifiers

DDI-103

Identifier Type: -

Identifier Source: org_study_id