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

This study has been completed.
Sponsor:
Collaborator:
LanZhou University
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01082796
First received: March 4, 2010
Last updated: March 8, 2010
Last verified: November 2009
  Purpose

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 Intervention
Genotype
Pharmacokinetic
Drug: Glipizide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Enrollment: 14
Study Start Date: November 2009
Study Completion Date: January 2010
Arms Assigned Interventions
CYP2C19 EMs group
cyp2c19*1/*1 carriers
Drug: Glipizide
Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
Other Name: Glucotrol XL®
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 Name: Glucotrol XL®

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 g) 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).

  Eligibility

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

Inclusion Criteria:

  • male
  • healthy
  • nonsmokers

Exclusion Criteria:

  • BMI > 24 or BMI < 19
  • had any family history of diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082796

Locations
China, Gansu
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
  More Information

Additional Information:
No publications provided

Responsible Party: Shanghai Institute of Materia Medica, Chinese Academy of Sciences, The First Affiliated Hospital of Lanzhou University
ClinicalTrials.gov Identifier: NCT01082796     History of Changes
Other Study ID Numbers: SIMM-DMPK-090903
Study First Received: March 4, 2010
Last Updated: March 8, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014