Cilostazol-Simvastatin Drug Interaction Study

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02431013

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias Peripheral Artery Disease	Drug: Simvastatin Drug: Pravastatin Drug: Cilostazol	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Simvastatin Simvastatin 40 mg on Day 1 & Day 8. Other Names: S Drug: Cilostazol Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin. Other Names: C
Active Comparator: 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.	Drug: Pravastatin Pravastatin 20 mg on Day 1 & Day 8. Other Names: P Drug: Cilostazol Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin. Other Names: C

Arm

Intervention/Treatment

Experimental: 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.

Drug: Simvastatin

Simvastatin 40 mg on Day 1 & Day 8.

Other Names:

Drug: Cilostazol

Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.

Other Names:

Active Comparator: 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.

Drug: Pravastatin

Pravastatin 20 mg on Day 1 & Day 8.

Other Names:

Drug: Cilostazol

Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.

Other Names:

Outcome Measures

Primary Outcome Measures

AUC (area under the time-concentration curve) of Simvastatin [up to 12 hours after Simvastatin dosing]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male subjects aged 20 - 45 years
With in 20% of ideal body weight,
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