Effect of Cilostazol on the Pharmacokinetics of Simvastatin

NCT01383395 | Completed Phase 1

• 1 other identifier: 2011-04-070
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of simvastatin

  Plasma concentration of simvastin on day 1 and day 6

  7 days

Study Arms (1)

simvastatin/cilostazol

EXPERIMENTAL

simvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6

Drug: simvastatin/cilostazol

Interventions

simvastatin/cilostazol DRUG

simvastatin/cilostazol

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 20 - 48 years
• A body mass index (BMI) in the range 19-27 kg/m2
• Provide written informed consent after being fully informed about the study procedures
• Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
• Determined eligible in the ECG, clinical laboratory tests and urinalysis

You may not qualify if:

• Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
• Use of medication within 10 days before first dose
• Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
• Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
• Whole blood donation during 60 days before the study
• Participation in other clinical trial within 90 days prior to scheduled study drug administration
• Subject judged not eligible for study participation by investigator

Sponsors & Collaborators

• Samsung Medical Center: lead
• Inje University: collaborator

Study Sites (1)

Samsung Medical Center Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Simvastatin; Cilostazol

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• JaeWook Ko, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 20, 2015

Record last verified: 2012-05

Locations

KR (1)