Clincosm LogoSign in Get a demo

Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects

Sponsor
Chinese Academy of Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01082796
Collaborator
LanZhou University (Other)
14
Enrollment
1
Location
2
Arms
2
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Blood samples were obtained from 127 unrelated healthy male Chinese subjects in Gansu Province. After genotyping, 14 subjects (age, 19-26; weight, 59.5-70.0 kg) were enrolled in the study. They were divided into two groups, EMs homo and PMs group. There were no significant differences in age or body weight seen in the two groups.

Each subject received 5 mg glipizide extended release tablet once daily for 7 days. For the first 6 days, glipizide was administered just after a standard breakfast. On day 7, after an overnight fast, each subject received a glipizide extended released tablet (Glucotrol XL, Pfizer, USA) with 100 mL water. Standard meals were given in 4 h and 10 h after dosing. Venous blood samples were collected immediately before and at 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 36, and 48 h after dosing. Blood samples, collected in EDTA tubes, were centrifuged (2500

  1. immediately for 10 min and plasma samples separated were stored at -80ºC until assay.

For safety, blood glucose levels were determined directly by use of a Glucose Meter (Accu-Chek, Roche, Germany) at 0, 2, 4, 6, 8, 10, 12, 14, 16, 20and 24 h after last dosing (on day 7).

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects
Study Start Date :
Nov 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: CYP2C19 EMs group

cyp2c19*1/*1 carriers

Drug: Glipizide
Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
Other Names:
  • Glucotrol XL®

    		•
    Other: CYP2C19 PMs group

    cyp2c19*2/*2 or *2/*3

    Drug: Glipizide
    Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
    Other Names:
  • Glucotrol XL®

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 40 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • male

      • healthy

      • nonsmokers

      Exclusion Criteria:

      • BMI > 24 or BMI < 19

      • had any family history of diabetes mellitus

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Departmant of Clinical Pharmacology, the First Affiliated Hospital of Lanzhou University Lanzhou Gansu China 730000

      Sponsors and Collaborators

      • Chinese Academy of Sciences
      • LanZhou University

      Investigators

      • Study Director: Da F Zhong, PH.D, Shanghai Institute of Materia Medica, Chinese Academy of Sciences

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01082796
      Other Study ID Numbers:
      • SIMM-DMPK-090903
      First Posted:
      Mar 9, 2010
      Last Update Posted:
      Mar 9, 2010
      Last Verified:
      Nov 1, 2009
      Additional relevant MeSH terms:
      Glipizide

      Study Results

      No Results Posted as of Mar 9, 2010