Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions - Full Text View

Sponsored by:	Ranbaxy Laboratories Limited
Information provided by:	Ranbaxy Inc.
ClinicalTrials.gov Identifier:	NCT00778778

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

Drug Information available for: Cefprozil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Crossover Assignment, Bio-equivalence Study
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.

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

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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ranbaxy Research Labs ( Dr. Tausif Monif )
Study ID Numbers:	AA27168
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778778
Health Authority:	Canada: Health Canada

Keywords provided by Ranbaxy Inc.:

Bioequivalence cefprozil 500mg tablets fasting conditions

Study placed in the following topic categories:

Cephalosporins
Cefprozil
Cefixime
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009