Back to resultsTo Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cefprozil 500 mg Tablets (Sandoz, GmbH)
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Antibiotics
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cefprozil 500 mg Tablets (Sandoz, GmbH)
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00881855
Brief Title
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
Official Title
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fed Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cefprozil 500 mg Tablets (Sandoz, GmbH)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
Intervention Type
Drug
Intervention Name(s)
Cefprozil 500 mg Tablets (Sandoz, GmbH)
Intervention Type
Drug
Intervention Name(s)
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Morelli, M.D.
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
We'll reach out to this number within 24 hrs