Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting
This study has been completed.
Sponsor:
Teva Pharmaceuticals USA
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835354
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
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Results First Received: June 18, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label |
| Condition: |
Healthy |
| Interventions: |
Drug: Cefprozil for oral suspension 250 mg/5 mL Drug: CEFZIL® for Oral Suspension 250 mg/5mL |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Cefprozil (Test) First | 250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period. |
| Cefzil® (Reference) First | 250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period. |
Participant Flow for 3 periods
Period 1: First Intervention
| Cefprozil (Test) First | Cefzil® (Reference) First | |
|---|---|---|
| STARTED | 13 | 13 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 1 |
| Adverse Event | 0 | 1 |
Period 2: Washout of 7 Days
| Cefprozil (Test) First | Cefzil® (Reference) First | |
|---|---|---|
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
Period 3: Second Intervention
| Cefprozil (Test) First | Cefzil® (Reference) First | |
|---|---|---|
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Cefprozil (Test) First | 250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period. |
| Cefzil® (Reference) First | 250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period. |
| Total | Total of all reporting groups |
Baseline Measures
| Cefprozil (Test) First | Cefzil® (Reference) First | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
13 | 13 | 26 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 13 | 26 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 8 | 5 | 13 |
| Male | 5 | 8 | 13 |
|
Race/Ethnicity, Customized
[units: participants] |
|||
| Black | 2 | 0 | 2 |
| White | 11 | 13 | 24 |
|
Ethnicity (NIH/OMB)
[units: participants] |
|||
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 13 | 12 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 13 | 13 | 26 |
Outcome Measures
| 1. Primary: | Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] |
| 2. Primary: | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] |
| 3. Primary: | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ] |