Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fasting Conditions - Full Text View

Sponsored by:	Ranbaxy Laboratories Limited
Information provided by:	Ranbaxy Inc.
ClinicalTrials.gov Identifier:	NCT00778557

Purpose

The study was conducted as a blinded, randomized, 3-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fasting conditions

Condition	Intervention
Healthy	Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

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:	A Three-Way Crossover, Blinded, Single-Dose, Fasting, Bioequivalence Study of One Test Formulation of Cefprozil 250 mg/5 mL Oral Suspension Versus Two Reference Formulation of Cefzil TM Powder for Oral Suspension (250 mg/5 mL) in Normal Healthy Non-Smoking Male and Female Subjects

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:

Bioequivalence [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	June 2005
Study Completion Date:	July 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)	Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
2: Active Comparator Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)	Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
3: Active Comparator Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)	Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

Detailed Description:

The study was designed to compare the rate and extent of absorption of cefprozil from the following products under fasting condition:

CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India)
Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)
Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA)

The bioequivalence of these formulations was assessed for cefprozil. The study will follow a randomized, 3-way cross over, blinded single dose, fasting design in 36 normal healthy, nonsmoking male and female subjects

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Non-smoking male or female with a minimum age of 18 years
Body Mass Index (BMI= weight/ height) greater than or equal to 18.5 kg/m3 and less than or equal to 29.9 kg/m3
Normal findings in physical examination, 12- lead ECG and vital signs (blood pressure between 100-140/60-90 mm Hg, heart rate between 50-90 beats/min, temperature between 35.8°C and 37.5 °C
Negative for drug abuse, nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects pregnancy serum (serum β-CG)
No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decided that they were not clinically significant
Female subjects who were surgically sterile for at least 6 months or post -menopausal for one year, or who avoided pregnancy prior to the study, during the study and up until one month after end of the study
Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by signed ICF

Exclusion Criteria:

Known history of hypersensitivity to cefprozil (e.g. Cefzil TM , cephalosporin antibiotics or penicillin antibiotics
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeltal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the principal investigator or Sub-investigator.
Presence of any significant physical or organ abnormality
Any history or evidence of food allergies
Any subject with history of drug abuse
Any significant illness
History of colitis
Significant recent history of Asthma
Any history of severe allergic reaction
Any subject with recent hi story of alcohol abuse
Use of any prescription medication within 14 days preceding study
Use of OTC medication within 7 days before study
Female subjects: use of contraceptives (oral, transdermal, implant, Mirena ®) within 30 days prior to drug administration or a depot injection of progesterone drug (eg. Depo-Provera®) within one year prior to drug administration
Female subjects with evidence of pregnancy or lactation
Any subject with blood drawn prior to the study during the conduct of clinic study other than BCR or within lock out period specified by previous study conducted by BCR
Participation in clinical trial with investigational drug within 30 days preceding study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778557

Locations

Canada, Ontario
Biovail Contract Research
Toronto, Ontario, Canada, M1L 454

Sponsors and Collaborators

Ranbaxy Laboratories Limited

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ranbaxy Research Laboratories ( Dr. Tausif Monif )
Study ID Numbers:	3098
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778557
Health Authority:	Canada: Health Canada

Keywords provided by Ranbaxy Inc.:

CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL, Bioequivalence fasting conditions

Study placed in the following topic categories:

Cefprozil
Healthy

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009