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

NCT ID: NCT01082796

Last Updated: 2010-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-01-31

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.

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).

Conditions

Genotype; Pharmacokinetic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CYP2C19 EMs group

cyp2c19\*1/\*1 carriers

Group Type: OTHER

Glipizide

Intervention Type: DRUG

Each subject received 5 mg glipizide extended release tablet once daily for 7 days.

CYP2C19 PMs group

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

Group Type: OTHER

Glipizide

Intervention Type: DRUG

Each subject received 5 mg glipizide extended release tablet once daily for 7 days.

Interventions

Glipizide

Each subject received 5 mg glipizide extended release tablet once daily for 7 days.

Intervention Type: DRUG

Other Intervention Names

Glucotrol XL®

Eligibility Criteria

Inclusion Criteria

• male
• healthy
• nonsmokers

Exclusion Criteria

• BMI > 24 or BMI < 19
• had any family history of diabetes mellitus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

The First Affiliated Hospital of Lanzhou University

Principal Investigators

Da F Zhong, PH.D

Role: STUDY_DIRECTOR

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Locations

Departmant of Clinical Pharmacology, the First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China

Countries

China

Related Links

http://english.simm.cas.cn/

Our organization

Other Identifiers

SIMM-DMPK-090903

Identifier Type: -

Identifier Source: org_study_id