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

Launched by RANBAXY LABORATORIES LIMITED · Oct 22, 2008

Keywords

ClinConnect Summary

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

1. CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)
2. Cefzil ® (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company USA) The bioequivalence of these formulations was assessed for cefprozil (Bristol-Myers Squibb Company, USA)

Thirty -two subjects (32) were recruited for the study of which 16 were males and 16 were females. All of them completed the study

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Non-smoking male or female with a minimum age of 18 years
• • 2. 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
• • 3. 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
• • 4. Negative for drug abuse, nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects pregnancy serum (serum β-CG)
• • 5. No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decided that they were not clinically significant
• • 6. 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
• • 7. Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by signed ICF
• Exclusion Criteria:
• Subject candidates who met the following criteria were excluded::
• • 1. Known history of hypersensitivity to cefprozil (e.g. Cefzil TM , cephalosporin antibiotics or penicillin antibiotics
• • 2. 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.
• • 3. Presence of any significant physical or organ abnormality
• • 4. Any history or evidence of food allergies
• • 5. Any subject with history of drug abuse
• • 6. Any significant illness
• • 7. History of colitis
• • 8. Significant recent history of Asthma
• • 9. Any history of severe allergic reaction
• • 10. Any subject with recent hi story of alcohol abuse
• • 11. Use of any prescription medication within 14 days preceding study
• • 12. Use of OTC medication within 7 days before study
• • 13. 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
• • 14. Female subjects with evidence of pregnancy or lactation
• • 15. 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
• • 16. Participation in clinical trial with investigational drug within 30 days preceding study