Cilostazol-Simvastatin Drug Interaction Study

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02431013
• Other study ID #: DDI-103
• Status: Recruiting
• Phase: Phase 1
• First received: April 23, 2015
• Last updated: April 29, 2015
• Start date: April 2015

Study information

• Verified date: April 2015
• Source: Ajou University School of Medicine
• Contact: Doo-Yeoun Cho, MD
• Phone: +82-31-219-4271
• Email: dooycho[@]ajou.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Simvastatin
Simvastatin 40 mg on Day 1 & Day 8.
• Pravastatin
Pravastatin 20 mg on Day 1 & Day 8.
• Cilostazol
Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the time-concentration curve) of Simvastatin		up to 12 hours after Simvastatin dosing	No
Secondary	Cmax (maximum plasma concentration) of Simvastatin		up to 12 hours after Simvastatin dosing	No
Secondary	Cmax (maximum plasma concentration) of Pravastatin		up to 12 hours after Pravastatin dosing	No
Secondary	AUC (area under the time-concentration curve) of Pravastatin		up to 12 hours after Pravastatin dosing	No