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Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 2, 2008
Last updated: February 27, 2009
Last verified: February 2009
The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.

Condition Intervention Phase
CYP2C19 Poor
Extensive Metabolizers
Drug: Rosuvastatin Calcium
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers [ Time Frame: Scheduled times during the 18 days that the study drug is taken ]
  • Blood levels for assessment of pharmacodynamic (lipid) parameters [ Time Frame: Days -1 and 18 ]

Secondary Outcome Measures:
  • Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers [ Time Frame: Screening through completion of the study ]

Estimated Enrollment: 50
Study Start Date: September 2008
Study Completion Date: February 2009
Arms Assigned Interventions
Experimental: Rosuvastatin Calcium Drug: Rosuvastatin Calcium
single oral dose on days 1, 4, 5, 6, 10-16, 17


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C>A, and CYP2C9.
  • Males and females aged 20-65, inclusive
  • Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.

Exclusion Criteria:

  • Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 *5 and *15, BCRP 421C>A and/or non wild-type CYP2C9
  • History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
  • History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
  • Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)
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Please refer to this study by its identifier: NCT00766025

Research Site
Taipei, Taiwan
Sponsors and Collaborators
Study Director: Regeio Mosquea-Garcia, MD AstraZeneca
Study Director: Robin Meng, MD, PhD AstraZeneca
Principal Investigator: Tzung-Dau Wang, MD Northern Taiwan University Hospital
  More Information

Responsible Party: Michael Cressman, Medical Science Executive Director, Clinical Development, Cardiovascular, AstraZeneca Pharmaceuticals Identifier: NCT00766025     History of Changes
Other Study ID Numbers: D3560C00059
Rosuvastatin Calcium
Study First Received: October 2, 2008
Last Updated: February 27, 2009

Keywords provided by AstraZeneca:
Taiwanese Subjects
Poor Metabolizers
Extensive Metabolizers
Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers

Additional relevant MeSH terms:
Calcium, Dietary
Rosuvastatin Calcium
Bone Density Conservation Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on April 21, 2017