Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fasting Conditions

The study was designed to compare the rate and extent of absorption of cefprozil from the following products under fasting condition:

• CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)
• Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)
• Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)

The bioequivalence of these formulations was assessed for cefprozil. The study will follow a randomized, 3-way cross over, blinded single dose, fasting design in 36 normal healthy, nonsmoking male and female subjects

Inclusion criteria

• Non-smoking male or female with a minimum age of 18 years
• Body Mass Index (BMI= weight/ height) greater than or equal to 18.5 kg/m3 and less than or equal to 29.9 kg/m3
• Normal findings in physical examination, 12- lead ECG and vital signs (blood pressure between 100-140/60-90 mm Hg, heart rate between 50-90 beats/min, temperature between 35.8°C and 37.5 °C
• Negative for drug abuse, nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects pregnancy serum (serum β-CG)
• No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decided that they were not clinically significant
• Female subjects who were surgically sterile for at least 6 months or post -menopausal for one year, or who avoided pregnancy prior to the study, during the study and up until one month after end of the study
• Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by signed ICF

Exclusion criteria

• Known history of hypersensitivity to cefprozil (e.g. Cefzil TM , cephalosporin antibiotics or penicillin antibiotics
• Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeltal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the principal investigator or Sub-investigator.
• Presence of any significant physical or organ abnormality
• Any history or evidence of food allergies
• Any subject with history of drug abuse
• Any significant illness
• History of colitis
• Significant recent history of Asthma
• Any history of severe allergic reaction
• Any subject with recent hi story of alcohol abuse
• Use of any prescription medication within 14 days preceding study
• Use of OTC medication within 7 days before study
• Female subjects: use of contraceptives (oral, transdermal, implant, Mirena ®) within 30 days prior to drug administration or a depot injection of progesterone drug (eg. Depo-Provera®) within one year prior to drug administration
• Female subjects with evidence of pregnancy or lactation
• Any subject with blood drawn prior to the study during the conduct of clinic study other than BCR or within lock out period specified by previous study conducted by BCR
• Participation in clinical trial with investigational drug within 30 days preceding study