Dyslipidemias, Peripheral Artery Disease
Conditions
Keywords
Drug-drug interaction, Pharmacokinetics
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.
Interventions
DRUGSimvastatin
Simvastatin 40 mg on Day 1 & Day 8.
DRUGPravastatin
Pravastatin 20 mg on Day 1 & Day 8.
DRUGCilostazol
Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC (area under the time-concentration curve) of Simvastatin | up to 12 hours after Simvastatin dosing |
Secondary
| 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 |
Countries
South Korea
Contacts
Primary ContactDoo-Yeoun Cho, MD
Outcome results
None listed