To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed 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 Apr 2005
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
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedMarch 29, 2017
April 1, 2009
Same day
April 14, 2009
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence based on AUC and Cmax
7 days
Study Arms (2)
1
EXPERIMENTALCefdinir 300 mg Capsule (Sandoz, Austria)
2
ACTIVE COMPARATOROmnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
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
Richard Larouche, M.D.
SFBC Anapharm
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 16, 2009
Study Start
April 1, 2005
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
March 29, 2017
Record last verified: 2009-04