Cilostazol-Simvastatin Drug Interaction Study

Ajou University School of Medicine

Status and phase: Unknown; Phase 1

Conditions: Peripheral Artery Disease; Dyslipidemias

Treatments: Drug: Cilostazol; Drug: Simvastatin; Drug: Pravastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02431013

DDI-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Simvastatin+Cilostazol

Experimental group

Description:

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.

Treatment:

Drug: Cilostazol

Drug: Simvastatin

Pravastatin+Cilostazol

Active Comparator group

Description:

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.

Treatment:

Drug: Cilostazol

Drug: Pravastatin