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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778557
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The study was conducted as a blinded, randomized, 3-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 fasting conditions


Condition Intervention
Healthy
Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: A Three-Way Crossover, Blinded, Single-Dose, Fasting, Bioequivalence Study of One Test Formulation of Cefprozil 250 mg/5 mL Oral Suspension Versus Two Reference Formulation of Cefzil TM Powder for Oral Suspension (250 mg/5 mL) in Normal Healthy Non-Smoking Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2005
Study Completion Date: July 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)
Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
Active Comparator: 2
Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)
Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
Active Comparator: 3
Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)
Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

Detailed Description:

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

  1. CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)
  2. Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)
  3. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778557

Locations
Canada, Ontario
Biovail Contract Research
Toronto, Ontario, Canada, M1L 454
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00778557     History of Changes
Other Study ID Numbers: 3098
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: Canada: Health Canada

Keywords provided by Ranbaxy Inc.:
CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL, Bioequivalence fasting conditions

Additional relevant MeSH terms:
Cefprozil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014