Trial Outcomes & Findings for Cefadroxil 500 mg Capsules Under Fasting Conditions (NCT NCT00834275)

NCT ID: NCT00834275

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	13	13
Washout of 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	13	13
Second Intervention COMPLETED	13	13
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cefadroxil 500 mg Capsules Under Fasting Conditions

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	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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=26 Participants 500 mg Cefadroxil Capsules test product dosed in either period.	Duricef® (Reference) n=26 Participants 500 mg Duricef® Capsules reference product dosed in either period.
Cmax (Maximum Observed Concentration)	16.595 ng/mL Standard Deviation 3.017	16.744 ng/mL Standard Deviation 3.316

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=26 Participants 500 mg Cefadroxil Capsules test product dosed in either period.	Duricef® (Reference) n=26 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)	50.933 ng*h/mL Standard Deviation 11.546	50.246 ng*h/mL Standard Deviation 11.226

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=26 Participants 500 mg Cefadroxil Capsules test product dosed in either period.	Duricef® (Reference) n=26 Participants 500 mg Duricef® Capsules reference product dosed in either period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	52.303 ng*h/mL Standard Deviation 11.628	51.770 ng*h/mL Standard Deviation 11.460

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

TEVA Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER