Status:
COMPLETED
Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Conditions:
Drug Interaction Potentiation
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, 2-period, 2-sequence, cross-over study.
Detailed Description
Background: Notions used to describe drug disposition are being reviewed as the roles of drug membrane transporters are being discovered. In the near past, simple biophysical principles - lipophilici...
Eligibility Criteria
Inclusion
- Vital Signs, EKG and Clinical Laboratory Values within the normal range
- Body mass index (BMI) \[20-29kg/m2\]
- Caucasian male
- Age between \[18-55\]
- Healthy by physical exam
- Non or ex-smoker
Exclusion
- Presence or history of intolerance or hypersensibility to proton pump inhibitors or HMG-CoA reductase inhibitors.
- Significant illness. History of cardiovascular, kidney, liver or gastrointestinal disease. Presence of cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- consumption of an investigational product or donation of blood in the previous 28 days preceding the study.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01146483
Start Date
April 1 2010
End Date
December 1 2011
Last Update
December 15 2011
Active Locations (1)
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1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W1T7