Pharmacodynamic Drug Interaction Between Cilostazol and Statins (SMCCPT-100)

Samsung Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Simvastatin; Drug: Cilostazol; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01870466

2011-11-004

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

Full description

Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

Enrollment: 63 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects aged 20 - 55 years
• A body mass index in the range 18.5 - 27 kg/m2
• Willingness to participate during the entire study period
• Written informed consent after being fully informed about the study procedures

Exclusion criteria

• Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
• Active bleeding or bleeding tendency
• History of gastrointestinal disease or surgery possibly affecting drug absorption
• History of clinically significant drug hypersensitivity
• Use of medication within 7 days before the first dose
• Heavy drinker (>140 g/week)
• Whole blood donation during 60 days before the study
• Judged not eligible for study participation by investigator

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 6 patient groups

C -> C + S

Experimental group

Description:

cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2

Treatment:

Drug: Cilostazol

Drug: Simvastatin

C + S -> C

Experimental group

Description:

cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2

Treatment:

Drug: Cilostazol

Drug: Simvastatin

S -> S + C

Experimental group

Description:

simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2

Treatment:

Drug: Cilostazol

Drug: Simvastatin

C + S -> S

Experimental group

Description:

cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2

Treatment:

Drug: Cilostazol

Drug: Simvastatin

R -> C + R

Experimental group

Description:

rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2

Treatment:

Drug: Rosuvastatin

Drug: Cilostazol

C + R -> R

Experimental group

Description:

cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2

Treatment:

Drug: Rosuvastatin

Drug: Cilostazol