Trial Outcomes & Findings for Cefprozil 500 mg Tablets Under Fasting Conditions (NCT NCT00840281)
NCT ID: NCT00840281
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 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
500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
|
Cefzil® (Reference) First
500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
19
|
19
|
|
First Intervention
COMPLETED
|
19
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
19
|
19
|
|
Washout of 7 Days
COMPLETED
|
19
|
19
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
19
|
19
|
|
Second Intervention
COMPLETED
|
19
|
19
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cefprozil 500 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Total
n=38 Participants
Total of all reporting groups
|
Cefprozil (Test) First
n=19 Participants
500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
|
Cefzil® (Reference) First
n=19 Participants
500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
32 participants
n=5 Participants
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
19 participants
n=5 Participants
|
19 participants
n=7 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=38 Participants
500 mg Cefprozil Tablets test product dosed in either period.
|
Cefzil® (Reference)
n=38 Participants
500 mg Cefzil® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
11.509 ng/mL
Standard Deviation 3.314
|
11.573 ng/mL
Standard Deviation 3.48
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Cefprozil (Test)
n=38 Participants
500 mg Cefprozil Tablets test product dosed in either period.
|
Cefzil® (Reference)
n=38 Participants
500 mg Cefzil® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
34.528 ng*h/mL
Standard Deviation 10.625
|
34.033 ng*h/mL
Standard Deviation 9.471
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Cefprozil (Test)
n=38 Participants
500 mg Cefprozil Tablets test product dosed in either period.
|
Cefzil® (Reference)
n=38 Participants
500 mg Cefzil® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
34.890 ng*h/mL
Standard Deviation 10.727
|
34.379 ng*h/mL
Standard Deviation 9.515
|
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