Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778778
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention
Healthy
Drug: cefprozil 500mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

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

Enrollment: 27
Study Start Date: May 2005
Study Completion Date: August 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 cefprozil tablets of BMS, USA
Drug: cefprozil 500mg tablets
Active Comparator: 3
CEFZIL ® 500 mg tablets, BMS Canada
Drug: cefprozil 500mg tablets

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.

  Eligibility

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

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
  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: NCT00778778

Locations
Canada, Quebec
MDS Pharma Services
Saint-Laurent, 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: NCT00778778     History of Changes
Other Study ID Numbers: AA27168
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 fasting conditions

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

ClinicalTrials.gov processed this record on August 01, 2014