Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects
Information source: Chinese Academy of Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genotype; Pharmacokinetic
Intervention: Glipizide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chinese Academy of Sciences Official(s) and/or principal investigator(s):
Da F Zhong, PH.D, Study Director, Affiliation: Shanghai Institute of Materia Medica, Chinese Academy of Sciences
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.
Clinical Details
Official title: Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- male
- healthy
- nonsmokers
Exclusion Criteria:
- BMI > 24 or BMI < 19
- had any family history of diabetes mellitus
Locations and Contacts
Departmant of Clinical Pharmacology, the First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu 730000, China
Additional Information
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