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

This study has been completed.
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00806013
First received: December 9, 2008
Last updated: January 26, 2010
Last verified: December 2008
History of Changes
  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:

Drug Information available for: Glipizide
U.S. FDA Resources

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

Ages Eligible for Study:   21 Years to 27 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Our organization  This link exits the ClinicalTrials.gov site
Chinese Academy of Sciences  This link exits the ClinicalTrials.gov site
National Natural Science Foundation of China  This link exits the ClinicalTrials.gov site
ShangHai Institutes For Biological Sciences  This link exits the ClinicalTrials.gov site
Liaoning University of TCM  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00806013     History of Changes
Other Study ID Numbers: SIMM-080601
Study First Received: December 9, 2008
Last Updated: January 26, 2010
Health Authority: China: National Natural Science Foundation

Keywords provided by Chinese Academy of Sciences:
genotype

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

ClinicalTrials.gov processed this record on May 16, 2013