Cilostazol-Simvastatin Drug Interaction Study

• Register: ClinicalTrials.gov
• Last refreshed on: 11 May 2015
• Main ID: NCT02431013
• Date of registration: 23/04/2015
• Prospective Registration: No
• Primary sponsor: Ajou University School of Medicine
• Public title: Cilostazol-Simvastatin Drug Interaction Study
• Scientific title: A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
• Date of first enrolment: April 2015
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02431013
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Doo-Yeoun Cho, MD

• Name: Doo-Yeoun Cho, MD

• Name: Doo-Yeoun Cho, MD
• Affiliation: Ajou University School of Medicine

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Dyslipidemias

Peripheral Artery Disease

Intervention(s)

Drug: Cilostazol

Drug: Pravastatin

Drug: Simvastatin

Primary Outcome(s)

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

Secondary Outcome(s)

Cmax (maximum plasma concentration) of Simvastatin [Time Frame: up to 12 hours after Simvastatin dosing]

AUC (area under the time-concentration curve) of Pravastatin [Time Frame: up to 12 hours after Pravastatin dosing]

Cmax (maximum plasma concentration) of Pravastatin [Time Frame: up to 12 hours after Pravastatin dosing]

Secondary ID(s)

DDI-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors