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Cilostazol-Simvastatin Drug Interaction Study

Information source: Ajou University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemias; Peripheral Artery Disease

Intervention: Simvastatin (Drug); Pravastatin (Drug); Cilostazol (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Ajou University School of Medicine

Official(s) and/or principal investigator(s):
Doo-Yeoun Cho, MD, Principal Investigator, Affiliation: Ajou University School of Medicine

Overall contact:
Doo-Yeoun Cho, MD, Phone: +82-31-219-4271, Email: dooycho@ajou.ac.kr

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

Clinical Details

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

Primary outcome: AUC (area under the time-concentration curve) of Simvastatin

Secondary outcome:

Cmax (maximum plasma concentration) of Simvastatin

Cmax (maximum plasma concentration) of Pravastatin

AUC (area under the time-concentration curve) of Pravastatin

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

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Doo-Yeoun Cho, MD, Phone: +82-31-219-4271, Email: dooycho@ajou.ac.kr

Ajou University Medical Center, Suwon, Gyeonggi 443-380, Korea, Republic of; Recruiting
Doo-Yeoun Cho, MD, Phone: +82-31-219-4271, Email: dooycho@ajou.ac.kr
Doo-Yeoun Cho, MD, Principal Investigator
Additional Information

Starting date: April 2015
Last updated: April 29, 2015

Page last updated: August 23, 2015

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