Clinical trial NCT02431013: Cilostazol-Simvastatin Drug Interaction Study
Official title: A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dyslipidemias
Peripheral Artery Disease
Keywords: Drug-drug interaction
Pharmacokinetics
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: AUC (area under the time-concentration curve) of Simvastatin
timeFrame: up to 12 hours after Simvastatin dosing
Secondary outcomes:
measure: Cmax (maximum plasma concentration) of Simvastatin
timeFrame: up to 12 hours after Simvastatin dosing
measure: Cmax (maximum plasma concentration) of Pravastatin
timeFrame: up to 12 hours after Pravastatin dosing
measure: AUC (area under the time-concentration curve) of Pravastatin
timeFrame: up to 12 hours after Pravastatin dosing
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyeonggi
Study officials:
affiliation: Ajou University School of Medicine
name: Doo-Yeoun Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: