Status:
COMPLETED
Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition) to asses...
Detailed Description
Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum of antimicrobial activity. A granule formulation has been developed to improve medication adherence of the...
Eligibility Criteria
Inclusion
- Healthy male or female aged between 18 and 55 years old (including the critical value).
- The body mass index is in the range of 19-28 kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
- Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements, and laboratory safety tests .
- The subjects have no family planning within 6 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
- The subjects could complete the study accorrding to the protocol.
Exclusion
- any history of hypersensitivity, needlesickness or idiosyncratic reactions to any food or drug, especially for penicillins or cephalosporins;
- hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
- any history of acute or chronic illness that might affect drug absorption, and/or metabolism;
- positive results for urine drug screening;
- any history of drug abuse in the past 5 years or drug use 3 months prior to screening;
- any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
- smoking more than 5 cigarettes per day during the 3 months prior to screening;
- blood donation, massive blood loss (\>400mL) or enrolled in other clinical trials 3 months prior to screening;
- any use of other prescription drugs (including contraceptive) 14 days prior to medication for this study;
- any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol products, grapefruit-containing or caffeine/xanthine-rich foodand beverages 48 h prior to medication for this study;
- the outcome of breath alcohol test \> 0mg /mL;
- dysphagia or having special dietary requirements;
- occurring acute disease in the screening period or before the medication;
- lactating or pregnant women;
- investigator-determined ineligibility.
Key Trial Info
Start Date :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04414254
Start Date
September 11 2018
End Date
January 30 2019
Last Update
June 4 2020
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003