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Comparative Bioavailability of Cefuroxime Axetil tablets in Healthy Chinese Volunteers: An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study

Comparative Bioavailability of Cefuroxime Axetil tablets in Healthy Chinese Volunteers: An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17011314
Enrollment
Unknown
Registered
2017-05-06
Start date
2017-05-31
Completion date
Unknown
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infection

Interventions

A:RT
B:TR
C:RT
D:TR
YJ:RT
YY:TR
YB:RT
YD:TR

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 45 years old (including 18 and 45 one full year of life), both men and women, single gender not less than one-third of the total; 2. Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg); Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 28 kg/m2; 3. According to past medical history, comprehensive physical examination and laboratory test, the researchers identified as healthy subjects; 4. Fertile woman should have negative pregnancy blood test ,and should take effective appropriate precautions from 14 days before the delivery to 6 months after the study; 5. Male should take effective appropriate precautions from 14 days before the delivery to 6 months after the study,and agree not to participate in sperm donation during the period; 6. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent; 7. Subjects Can communicate well with the researchers and comply with the requirements of the entire study, and would like to check in phase I clinical research unit in accordance with the relevant provisions.

Exclusion criteria

Exclusion criteria: 1. Subject can't tolerate venipuncture; 2. Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator product; 3. Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc.; 4. Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination ) results judged as clinical significance of abnormal; 5. Hematology screening for HIV antibodies or HBV surface antigen or HCV antibody or TP antibody positive; 6. Women who are pregnant, pregnant, or plan to become pregnant in the near future; 7. The pregnancy test positive; 8. Male subjects did not take effective contraceptive measures or their spouse planned to conceive in the next six months; 9. Mental or legal disability; 10. History of prescription drug abuse and / or illicit drug abuse in the past 6 months; within 6 months prior to screening has a history of alcohol abuse, that drinking more than 14 units of alcohol a week (1 = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL liquor alcohol content of 40%, 5 oz or 150 mL wine); 11. within 6 months prior to screening smoking more than five cigarettes a day; 12. drug abuse or alcohol test positive; 13. Subjects have a history of hospitalization or surgery within 3 months before screening history (except appendicitis); 14. Participating in other clinical trials within the past 3 months; 15. Blood donation or a history of acute blood loss (more than 400 mL) or 1 months after the end of the test plan to blood donors; 16. use any other drugs within 2 weeks before the trial; 17. Subjects who drink strong tea, coffee and/or caffeinated drinks more than 1 l every day; 18. Subjects cannot understand the content of the informed consent and other do not accord with standard of trial; 19. Unsuitable to participate in the trial considered by the researchers (such as weak, etc.).

Design outcomes

Primary

MeasureTime frame
Cmax;AUC0-t;AUC0-inf;

Contacts

Public ContactShentu Jianzhong

the First Affiliated Hospital, College of Medicine, Zhejiang University

stjz@zju.edu.cn+86 13957111817

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026