A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Simvastatin
- Conditions
- Dyslipidemias
- Sponsor
- Ajou University School of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- AUC (area under the time-concentration curve) of Simvastatin
- Last Updated
- 11 years ago
Overview
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.
Investigators
Doo-Yeoun Cho
Assistant Professor
Ajou University School of Medicine
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
Arms & Interventions
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.
Intervention: Simvastatin
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.
Intervention: Cilostazol
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.
Intervention: Pravastatin
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.
Intervention: Cilostazol
Outcomes
Primary Outcomes
AUC (area under the time-concentration curve) of Simvastatin
Time Frame: up to 12 hours after Simvastatin dosing
Secondary Outcomes
- 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)
- Cmax (maximum plasma concentration) of Simvastatin(up to 12 hours after Simvastatin dosing)