Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin

Organon and Co0 sites18 target enrollmentMarch 2004

ConditionsHypercholesterolemia

InterventionsSCH 58235 pitavastatin

DrugsSCH 58235 pitavastatin

Overview

Phase: Phase 1
Intervention: SCH 58235
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Enrollment: 18
Primary Endpoint: Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

September 2004

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels.
•Aged 20 years or over and 65 years or below when the informed consent is obtained.
•Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI \[Body Mass Index: body weight (kg)/height (m)2\] ranging from 16.5 to 27.5.

Exclusion Criteria

•Patients meeting any one of the following conditions are excluded from the study.
•Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
•Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
•Subjects with past history of alcohol or drug dependence.
•Subjects with past history of mental disorder.
•Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis.
•Subjects who used any drug within 2 weeks of investigational product administration in Period
•Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period
•Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product.
•Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination)

Arms & Interventions

Group A

SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)

Intervention: SCH 58235