Study in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers receiving Rosuvastatin
Study identifier:D3560C00059
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium
Medical condition
CYP2C19 Poor
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Rosuvastatin Calcium
Sex
All
Actual Enrollment
50
Study type
Interventional
Age
20 Years - 65 Years
Date
Study Start Date: 01 Sept 2008
Primary Completion Date: -
Study Completion Date: 01 Feb 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosuvastatin Calcium | Drug: Rosuvastatin Calcium single oral dose on days 1, 4, 5, 6, 10-16, 17 |
Contacts
Investigators
Principal Investigator
Regeio Mosquea-Garcia
AstraZeneca Pharmaceuticals
