Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: SCH 58235 (Drug); pitavastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Schering-Plough
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.
Clinical Details
Official title: Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Secondary outcome: Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I).Adverse events, laboratory tests results, and vital signs.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Male.
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 1.
- Subjects who have drawn more than 400 mL of blood within 12 weeks before
administration day in Period 1.
- 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)
- Subjects who the investigator judges are inappropriate to participate in the study.
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: September 2004
Last updated: April 4, 2008
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