Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers

• Status: Completed
• Trial end date: 2019-01-30
• Target enrollment: 0
• Participant gender: All

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 assess the bioequivalence between two formulations of cefprozil.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Cefprozil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.