Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778245
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.


Condition Intervention
Healthy
Drug: cefprozil 500mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open - Label, Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg Cefprozil Tablets in Healthy Adult Volunteers Under Fed Conditions.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

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

Enrollment: 26
Study Start Date: May 2005
Study Completion Date: October 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cefprozil 500mg tablets of Ranbaxy
Drug: cefprozil 500mg tablets
Active Comparator: 2
CEFZIL ® 500 mg tablets of Bristol-Myers Squibb Company, USA
Drug: cefprozil 500mg tablets

Detailed Description:

A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.

Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject candidates must fulfill all of the following inclusion criteria t be eligible for participation in the study, unless otherwise specified:

    1. Healthy adult male or female volunteers, 18 to 55 years of age
    2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
    3. Medically healthy subjects with clinically normal laboratory profiles and ECGs
    4. Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
  • Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
  • IUD in place for at least 3 months
  • Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
  • Surgical sterilization of the partner (vasectomy for 6 months minimum)
  • Hormonal contraceptives for at least 3 months prior to the first dose of the study
  • Other birth control methods may be deemed acceptable e) Post menopausal women with amenorrhea for at least 2 years will be eligible f) Voluntarily consent to participate in the study

Exclusion Criteria:

  • Subject candidates must not be enrolled in the study if they meet any of the following criteria:

    1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
    2. In addition, history or presence of:
  • alcohol or drug abuse within the past year
  • hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin c) Female subjects who are pregnant or lactating d) Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study e) Subjects who through completion of the study, would have donated in excess of:
  • 500 mL of blood in 14 days
  • 1500 mL of blood in 180 days
  • 2500 mL of blood in 1 year f) Subjects who have participated in another clinical trial within 28 days prior to the first dose.
  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: NCT00778245

Locations
Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research labs
ClinicalTrials.gov Identifier: NCT00778245     History of Changes
Other Study ID Numbers: AA27169
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: Canada: Health Canada

Keywords provided by Ranbaxy Inc.:
Bioequivalence cefprozil 500mg tablets fed conditions

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

ClinicalTrials.gov processed this record on July 24, 2014