Trial Outcomes & Findings for Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting (NCT NCT00835354)
NCT ID: NCT00835354
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Blood samples collected over a 12 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
13
|
|
First Intervention
COMPLETED
|
13
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout of 7 Days
STARTED
|
13
|
12
|
|
Washout of 7 Days
COMPLETED
|
13
|
12
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
13
|
12
|
|
Second Intervention
COMPLETED
|
13
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
Baseline Characteristics
Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting
Baseline characteristics by cohort
| Measure |
Cefprozil (Test) First
n=13 Participants
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
n=13 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Cefprozil (Test)
n=25 Participants
250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
|
Cefzil® (Reference)
n=25 Participants
250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
4.367 ng/mL
Standard Deviation 0.711
|
4.915 ng/mL
Standard Deviation 0.859
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Cefprozil (Test)
n=25 Participants
250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
|
Cefzil® (Reference)
n=25 Participants
250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
14.211 ng*h/mL
Standard Deviation 2.15
|
15.776 ng*h/mL
Standard Deviation 2.702
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Cefprozil (Test)
n=25 Participants
250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
|
Cefzil® (Reference)
n=25 Participants
250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
14.495 ng*h/mL
Standard Deviation 2.204
|
16.048 ng*h/mL
Standard Deviation 2.72
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER