Pharmacokinetic Clinical Trial
Official title:
Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects
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.
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).
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04531150 -
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
|
Phase 1 | |
| Completed |
NCT03437265 -
A Pharmacokinetic Study of PLENVU® in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03979989 -
Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)
|
Phase 1 | |
| Completed |
NCT00743912 -
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05367011 -
Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU
|
||
| Completed |
NCT06126562 -
A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00745264 -
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
|
Phase 1 | |
| Completed |
NCT03344627 -
Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
|
N/A | |
| Terminated |
NCT02696954 -
Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03714568 -
Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.
|
Phase 1 | |
| Recruiting |
NCT04080895 -
Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT04735913 -
Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults
|
Early Phase 1 | |
| Completed |
NCT03011996 -
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
|
Phase 1 | |
| Completed |
NCT00681395 -
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
|
Phase 1 | |
| Completed |
NCT04617509 -
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
|
Phase 1 | |
| Terminated |
NCT03059511 -
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
|
Phase 1 | |
| Withdrawn |
NCT05938608 -
A Study to Assess the Availability of Oral Primaquine and Its Inert Metabolite, Carboxyprimaquine, in the Body
|
Phase 1 | |
| Completed |
NCT01091532 -
A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
|
Phase 1 | |
| Completed |
NCT03951402 -
Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT03882762 -
A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol
|
Phase 1 |