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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1L 454
      • Biovail Contract Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

• Sponsor: Ranbaxy Laboratories Limited

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 22, 2008
• First Posted (Estimate): October 23, 2008

Study Record Updates

• Last Update Posted (Estimate): October 23, 2008
• Last Update Submitted That Met QC Criteria: October 22, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL, Bioequivalence fasting conditions
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefprozil
• Other Study ID Numbers: 3098