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Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806013
First Posted: December 10, 2008
Last Update Posted: January 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese Academy of Sciences
  Purpose
The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study the Effects of CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide in Healthy Chinese Subject

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Biospecimen Retention:   Samples With DNA
The whole blood samples of each person are stored at -80℃.

Enrollment: 36
Study Start Date: August 2008
Study Completion Date: December 2008
Groups/Cohorts
1
CYP2C9*1/*1 and CYP2C19*1/*1 alleles carrier
2
CYP2C19 PMs (CYP2C19*2/*2, CYP2C19*2/*3 or CYP2C19*3/*3)
3
CYP2C9*1/*3 and CYP2C19*1/*1 alleles carrier

Detailed Description:
Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 27 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Male Chinese subjects with different geontype of CYP2C9 and CYP2C19 were enrolled in this study. They are divided into three groups by different geontype.
Criteria

Inclusion Criteria:

  • nonsmokers and in good health

Exclusion Criteria:

  • family history of diabetes mellitus
  • taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806013


Locations
China, Liaoning
The second hospital to Liaoning University of TCM
Shenyang, Liaoning, China, 201203
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
Principal Investigator: Bo Tan Shanghai Institute of Materia Medica, Chinese Academy of Sciences
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00806013     History of Changes
Other Study ID Numbers: SIMM-080601
First Submitted: December 9, 2008
First Posted: December 10, 2008
Last Update Posted: January 27, 2010
Last Verified: December 2008

Keywords provided by Chinese Academy of Sciences:
genotype

Additional relevant MeSH terms:
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs