Trial Outcomes & Findings for Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects. (NCT NCT00835081)
NCT ID: NCT00835081
Last Updated: 2024-08-19
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
2024-08-19
Participant Flow
Participant milestones
| Measure |
Cefadroxil (Test) First
500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
|
Duricef® (Reference) First
500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
13
|
|
First Intervention
COMPLETED
|
13
|
13
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
13
|
13
|
|
Washout of 7 Days
COMPLETED
|
12
|
13
|
|
Washout of 7 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
12
|
13
|
|
Second Intervention
COMPLETED
|
12
|
13
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cefadroxil (Test) First
500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
|
Duricef® (Reference) First
500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
|
|---|---|---|
|
Washout of 7 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
Baseline characteristics by cohort
| Measure |
Cefadroxil (Test) First
n=13 Participants
500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
|
Duricef® (Reference) First
n=13 Participants
500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 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 |
Cefadroxil (Test)
n=25 Participants
500 mg Cefadroxil Capsules test product dosed in either period.
|
Duricef® (Reference)
n=25 Participants
500 mg Duricef® Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
12.024 ng/mL
Standard Deviation 1.405
|
11.9 ng/mL
Standard Deviation 2.688
|
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 |
Cefadroxil (Test)
n=25 Participants
500 mg Cefadroxil Capsules test product dosed in either period.
|
Duricef® (Reference)
n=25 Participants
500 mg Duricef® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
42.656 ng*h/mL
Standard Deviation 7.063
|
42.685 ng*h/mL
Standard Deviation 7.572
|
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 |
Cefadroxil (Test)
n=25 Participants
500 mg Cefadroxil Capsules test product dosed in either period.
|
Duricef® (Reference)
n=25 Participants
500 mg Duricef® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
43.987 ng*h/mL
Standard Deviation 7.149
|
44.109 ng*h/mL
Standard Deviation 7.631
|
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