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

NCT ID: NCT00778245

Last Updated: 2008-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Bioequivalence cefprozil 500mg tablets fed conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

cefprozil 500mg tablets of Ranbaxy

Group Type EXPERIMENTAL

cefprozil 500mg tablets

Intervention Type DRUG

2

CEFZIL ® 500 mg tablets of Bristol-Myers Squibb Company, USA

Group Type ACTIVE_COMPARATOR

cefprozil 500mg tablets

Intervention Type DRUG

Interventions

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cefprozil 500mg tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ranbaxy Laboratories Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Ranbaxy Research labs

Locations

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MDS Pharma Services

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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http://clinicalstudies.ranbaxy.com

Related Info

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

http://www.fda.gov/opacom/7alerts.html

Related Info

Other Identifiers

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AA27169

Identifier Type: -

Identifier Source: org_study_id