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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834574 |
The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cefdinir for oral suspension 250 mg/5mL Drug: OMNICEF® for oral suspension 250 mg/5mL |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of Cefdinir for Oral Suspension 250 mg/5mL Under Fasting Conditions |
Enrollment: | 32 |
Study Start Date: | February 2005 |
Study Completion Date: | March 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cefdinir for oral suspension 250 mg/5mL
1 x 250 mg/5mL, single dose fasting
|
2: Active Comparator |
Drug: OMNICEF® for oral suspension 250 mg/5mL
1 x 250 mg/5mL, single dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Clinical laboratory measurements will include the following:
Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion Criteria:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 | |
Bioassay Laboratory, Inc. | |
Houston, Texas, United States, 77099 |
Principal Investigator: | Soran Hong, M.D. | Novum Pharmaceutical Research Services |
Study ID Numbers: | B056501 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834574 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Anti-Bacterial Agents Cefdinir Healthy |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Cefdinir Pharmacologic Actions |