Trial Outcomes & Findings for Cefdinir Capsules 300 mg, Fasting (NCT NCT00835484)
NCT ID: NCT00835484
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
300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
|
Omnicef® (Reference) First
300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules 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
|
16
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
16
|
|
Second Intervention
COMPLETED
|
16
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cefdinir Capsules 300 mg, Fasting
Baseline characteristics by cohort
| Measure |
Cefdinir (Test) First
n=16 Participants
300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
|
Omnicef® (Reference) First
n=16 Participants
300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules 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
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 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=32 Participants
300 mg Cefdinir Capsules test product dosed in either period.
|
Omnicef® (Reference)
n=32 Participants
300 mg Omnicef® Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
2995.84 ng/mL
Standard Deviation 882.84
|
3063.65 ng/mL
Standard Deviation 823.85
|
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=32 Participants
300 mg Cefdinir Capsules test product dosed in either period.
|
Omnicef® (Reference)
n=32 Participants
300 mg Omnicef® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
13953.75 ng*h/mL
Standard Deviation 4108.87
|
13795.54 ng*h/mL
Standard Deviation 3892.54
|
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=32 Participants
300 mg Cefdinir Capsules test product dosed in either period.
|
Omnicef® (Reference)
n=32 Participants
300 mg Omnicef® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
14388.7 ng*h/mL
Standard Deviation 4101.49
|
14154.64 ng*h/mL
Standard Deviation 3897.22
|
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