ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01082796
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : March 9, 2010
Sponsor:
Collaborator:
LanZhou University
Information provided by:
Chinese Academy of Sciences

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
Genotype Pharmacokinetic Drug: Glipizide Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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®




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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): 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

Additional Information:
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
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: November 2009

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