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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778739
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fed conditions

Condition or disease Intervention/treatment Phase
Healthy Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefprozil 250 mg/5 mL Oral Suspension Versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) in Normal Healthy Non-Smoking Male and Female Subjects
Study Start Date : June 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Cefprozil

Arm Intervention/treatment
Experimental: 1
Active Comparator: 2

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00778739

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Canada, Ontario
Biovail Contract Research,
Toronto, Ontario, Canada, MIL 4S4
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
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Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories Identifier: NCT00778739     History of Changes
Other Study ID Numbers: 3079
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
bioequivalence 1) CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL fed conditions

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents