To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fasting Conditions.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2004
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedMarch 29, 2017
April 1, 2009
1 month
April 14, 2009
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence based on AUC and Cmax
15 days
Study Arms (2)
1
EXPERIMENTALCefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
2
ACTIVE COMPARATORCefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)
Interventions
Eligibility Criteria
You may qualify if:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
You may not qualify if:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdy L. Shenouda, M.D.
MDS Pharma Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
May 1, 2004
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
March 29, 2017
Record last verified: 2009-04