None listed
Conditions
Interventions
Fasting T-R group:After a blank blood sample was collected in the morning of the administration day, the test preparation was taken orally on an empty stomach. The reference reagent was given orally i
Fasting R-T group:After a blank blood sample was collected in the morning of the administration day, the reference preparation was taken orally on an empty stomach. The test reagent was given orally i
High-fat postprandial T-R group :After a blank blood sample was collected on the morning of administration, the test preparation was taken orally after a high-fat meal. The reference reagent was give
High-fat postprandial R-T group:After a blank blood sample was collected on the morning of administration, the reference preparation was taken orally after a high-fat meal. The test reagent was given
Pre-experiments Fasting T-R group:After a blank blood sample was collected in the morning of the administration day, the test preparation was taken orally on an empty stomach. The reference reagent wa
Pre-experiments Fasting R-T group:After a blank blood sample was collected in the morning of the administration day, the reference preparation was taken orally on an empty stomach. The test reagent wa
Pre-experiments High-fat postprandial T-R group:After a blank blood sample was collected on the morning of administration, the test preparation was taken orally after a high-fat meal. The reference re
Pre-experiments High-fat postprandial R-T group:After a blank blood sample was collected on the morning of administration, the reference preparation was taken orally after a high-fat mea
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as subjects, and sign an informed consent form before any research procedure begins; 2. Aged > 18 years (including critical value); 3. Gender: both men and women, the gender ratio is appropriate; 4. Male weight >= 50.0kg, female weight >= 45.0kg, body mass index (BMI) within the range of 19.0-26.0 kg/m2 (both include boundary values); 5. The subjects voluntarily take effective contraceptive measures during the trial (from the beginning of screening to 3 months after the end of the trial); 6. The subjects can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Levocetirizine or its excipients (lactose, hypromellose, sucralose, sodium bicarbonate, sodium acetate trihydrate, glacial acetic acid, maltitol, glycerin, methylparaben Esters, propylparaben, saccharin, triacetin, natural and artificial flavors, dl-a-tocopherol, etc.) with a history of allergies; people with a history of allergies to two or more drugs, foods, etc. ; 2. (Inquiry) History of dysphagia or any gastrointestinal disease that affects drug absorption; 3. (Inquiry) Have a history of mental, neurological-related diseases or family history of genetic diseases, such as epilepsy, depression, etc.; 4. (Inquiry) Any history of surgery, trauma, or planning to undergo surgery during the study period that may affect the safety of the trial or the in vivo process of the drug; 5. (Inquiry) Have used any medicines, health products, Chinese herbal medicines within 2 weeks before screening; 6. (Inquiry) Whether you have used drugs within 3 months before screening; 7. (Inquiry) Those who have a history of drug abuse within 6 months before screening; 8. (Inquiry) Those who smoked more than 5 cigarettes per day within 3 months before screening, or who could not stop using any tobacco products during the trial; 9. (Inquiry) Drink more than 14 units per week within 3 months before screening (1 unit = 17.7mL ethanol, i.e. 1 unit = 357mL beer with 5% alcohol content or 43mL liquor with 40% alcohol content or 147mL 12% alcohol), or those who cannot abstain during the trial; 10. (Inquiry) Those who drink excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening, or those who cannot be interrupted during the test; 11. (Inquiry) Those who have participated in other drug clinical trials within 3 months before administration or who have not participated in clinical trials in person; 12. (Inquiry) Those who donated blood within 3 months before screening, including blood component or massive loss (>=400mL), who received blood transfusion or used blood products, and those who planned to donate blood during the trial; 13. (Inquiry) Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the study; 14. (Inquiry) whether the subject (female) is breastfeeding; 15. (Inquiry) The subjects and their partners have a pregnancy plan or a sperm or egg donation plan during the trial (from the start of screening to within 3 months after the end of the trial), and are unwilling or unable to take effective contraceptive measures voluntarily; 16. (Inquiry) Those who cannot tolerate venipuncture, those who have a history of fainting with needles and blood; 17. (Inquiry) Lactose or fructose intolerance (those who have experienced milk-drinking diarrhea); 18. (Inquiry) Those who have special requirements for diet and cannot accept a unified diet; 19. Urine drug screening [morphine, ketamine, methamphetamine, MDMA, tetrahydrocannabinol acid] positive or smoke test results are positive; 20. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function), 12-lead electrocardiogram results show abnormal clinical significance; 21. Patients with impaired renal function (creatinine clearance < 80mL/min, Ccr=[(140-age) x body weight (kg)]/[0.818 x creatinine (umol/L)], multiplied by 0.85 for female result); 22. Alcohol breath test results greater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of levocetirizine in the blood plasma; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed