Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting 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: NCT00778778
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Information provided by:
Ranbaxy Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: cefprozil 500mg tablets Not Applicable

Detailed Description:

This was a blinded, randomized, single dose, 3-way crossover comparative bioavailability study performed on 27 healthy adult volunteers (13 males and 14 females). In each period, subjects were housed from at least 10 hours before dosing until after the 10 hour post dose events. Subjects received a single oral 500 mg cefprozil dose of their assigned formulation, with 240 mL of water under fasting condition. Food was restricted from 10 hours before dosing until 4 hours post dose and water was not permitted from 2 hours before dosing and was restricted until 2 hours following dosing but was allowed ad libitum at all other times. The doses were separated by a washout period of 14 days.

A total of twenty seven (27) healthy adult volunteers (13 males and 14 females) were enrolled in the study, out of which only twenty four (24) subjects (11 males and 13 females) completed the clinical phase of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Blinded, Comparative, Randomized, Single-Dose, Three Way Crossover Bioavailability Study of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg Cefprozil Tablets in Healthy Adult Volunteers Under Fasting Conditions.
Study Start Date : May 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Cefprozil

Arm Intervention/treatment
Experimental: 1
Cefprozil 500mg tablets of ranbaxy
Drug: cefprozil 500mg tablets
Active Comparator: 2
CEFZIL ® 500 mg cefprozil tablets of BMS, USA
Drug: cefprozil 500mg tablets
Active Comparator: 3
CEFZIL ® 500 mg tablets, BMS Canada
Drug: cefprozil 500mg tablets

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject candidates fulfilled all of the following inclusion criteria to be eligible for the participation in the study, unless otherwise specified.

    1. Healthy adult male or female volunteers, 18 - 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, vital signs and ECGs.
    4. Females of childbearing potential were to be either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or 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 have been deemed acceptable e) Postmenopausal women with amenorrhea for at least 2 years were eligible f) Voluntarily consented to participate in the study

Exclusion Criteria:

  • Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:

    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 :
  • alcoholism or drug abuse within the past year;
  • hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin;
  • Female subjects who were pregnant or lactating. c) Positive results on HIV, HbsAg and/ or HCV tests. d) Subjects who were 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, or
  • 1500 mL of blood in 180 days, or
  • 2500 mL of blood in 1 year. f) Subjects who participated in another clinical trial within 28 days prior to the first dose

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): NCT00778778

Canada, Quebec
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs Identifier: NCT00778778     History of Changes
Other Study ID Numbers: AA27168
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

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

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