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Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778739 |
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
Condition | Intervention |
---|---|
Healthy |
Drug: CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefprozil 250 mg/5 mL Oral Suspension Versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) in Normal Healthy Non-Smoking Male and Female Subjects |
Enrollment: | 32 |
Study Start Date: | June 2005 |
Study Completion Date: | July 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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 |
The study was designed to compare the rate and extent of absorption of cefprozil from the following products under fed condition:
Thirty -two subjects (32) were recruited for the study of which 16 were males and 16 were females. All of them completed the study
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subject candidates who met the following criteria were excluded::
Responsible Party: | Ranbaxy Research Laboratories ( Dr. Tausif Monif ) |
Study ID Numbers: | 3079 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778739 History of Changes |
Health Authority: | Canada: Health Canada |
bioequivalence 1) CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL fed conditions |
Anti-Bacterial Agents Cefprozil Malnutrition Healthy |
Anti-Infective Agents Anti-Bacterial Agents Cefprozil Therapeutic Uses Pharmacologic Actions |