Pharmacokinetics and drug-drug interactions in human
Conditions
Interventions
1:A single oral administration of imrecoxib on day one
A single oral administration of fluconazole on day 9 and successive medication for 7 days
Oral administration of fluconazole combined with celecoxib on day 15.
Sponsors
Institute of Clinical Pharmacy, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male; 2. Aged 18~40 years; 3. Body weight: Body Mass Index (BMI)[=weight (kg)/height (m)2] within 19~24; 4. Health: Subjects with no history of heartr,liver, kidney, digestive tract, nervous system diseases. Physical examination and laboratory examination results are normal or abnormal without clinical significance, ECG normal or abnormal withou clinical significance; 5. Subjects did not take grapefruit and other citrus fruit or fruit juice and alcoholic beverages at 36h before administration and during the trial; 6. All subjects are voluntary to take part in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. People who are allergic to the investigational drug and other ingredients in the formulation of preparation; 2. People who have heart, liver, kidney, gastrointestinal tract, mental disease and hematological diseases may affect the safety of drug and pharmacokinetic behavior; 3. People who have other acute or chronic diseases may affect drug absorption and metabolism; 4. Drug abusers or alcohol consumers and people who smoke, drink tea or coffee or alcohol more than 1L/ days within 36 hours prior to the administration; 5. HbsAg positive or HCV positive or HIV positive; 6. Subjects who loss blood or blood donation over 200 ml within two months before the study; 7. Subjects in any clinical drug study within two months before the study; 8. Subjects who took any other medications within two weeks before the study or other medications but the prototype and the main metabolites were not completely eliminated within four weeks before the study; 9. Subjects who took medications which may affect drug metabolism(Such as the phenobarbital, phenytoin)or drug absorption (laxatives, metoclopramide, loperamide, antacids, H2- receptor antagonist) for many times within four weeks before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of imrecoxib;plasma concentration of hydroxyl metabolite of Imrecoxib;plasma concentration of carboxyl metabolite of Imrecoxib; | — |
Countries
China
Contacts
Public ContactPeng Wenxing
Outcome results
None listed