Trial Outcomes & Findings for Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting (NCT NCT00835549)
NCT ID: NCT00835549
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood samples collected over a 14 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Cefdinir (Test) First
250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
|
Omnicef® (Reference) First
250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
16
|
16
|
|
Washout of 7 Days
COMPLETED
|
14
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
14
|
16
|
|
Second Intervention
COMPLETED
|
14
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cefdinir (Test) First
250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
|
Omnicef® (Reference) First
250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
|
|---|---|---|
|
Washout of 7 Days
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
Baseline characteristics by cohort
| Measure |
Cefdinir (Test) First
n=16 Participants
250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
|
Omnicef® (Reference) First
n=16 Participants
250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 14 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Cefdinir (Test)
n=30 Participants
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
|
Omnicef® (Reference)
n=30 Participants
250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
1477.573 ng/mL
Standard Deviation 573.068
|
1484.677 ng/mL
Standard Deviation 531.404
|
PRIMARY outcome
Timeframe: Blood samples collected over a 14 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Cefdinir (Test)
n=30 Participants
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
|
Omnicef® (Reference)
n=30 Participants
250mg/5mL Omnicef® 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)
|
8009.082 ng*h/mL
Standard Deviation 3066.97
|
7851.736 ng*h/mL
Standard Deviation 2911.323
|
PRIMARY outcome
Timeframe: Blood samples collected over a 14 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Cefdinir (Test)
n=30 Participants
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
|
Omnicef® (Reference)
n=30 Participants
250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
8103.237 ng*h/mL
Standard Deviation 3123.887
|
7933.332 ng*h/mL
Standard Deviation 2957.041
|
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