Study the Effects of CYP2C Polymorphisms on the Pharmacok... | NCT00806013

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

NCT00806013

Sponsor

Chinese Academy of Sciences

Status

Completed

Last Update Posted

Jan 27, 2010Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Not provided

Completion Date

Dec 2008Actual

First Submitted Date

Dec 9, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2010

Last Update Posted Date

Jan 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		CYP2C91/1 and CYP2C191/1 alleles carrier
2		CYP2C19 PMs (CYP2C192/2, CYP2C192/3 or CYP2C193/3)
3		CYP2C91/3 and CYP2C191/1 alleles carrier

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

27 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Tan	Shanghai Institute of Materia Medica, Chinese Academy of Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The second hospital to Liaoning University of TCM		Shenyang	Liaoning	201203	China

References Module

Citations

Not provided

Label	URL
Our organization	View source
Chinese Academy of Sciences	View source
Liaoning University of TCM