Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fed Conditions

NCT00778739 | Completed DMC

• 1 other identifier: 3079
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted as an open-label, randomized, 2-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 fed conditions

Conditions

Healthy

Keywords

bioequivalence 1) CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL fed conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

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

2

ACTIVE COMPARATOR

CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

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

Interventions

CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL DRUG

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject candidates who met the following criteria were excluded::
• 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

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Biovail Contract Research,

Toronto, Ontario, MIL 4S4, Canada

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Interventions

Cefprozil; Suspensions

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: June 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: July 1, 2005
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

CA (1)