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The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefadroxil 500 mg Capsules | Drug | 1 x 500 mg |
| |
| DURICEF® capsules 500 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Observed Concentration) | Bioequivalence based on Cmax. | Blood samples collected over a 12 hour period. |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on AUC0-t. | Blood samples collected over a 12 hour period. |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on AUC0-inf. | Blood samples collected over a 12 hour period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Y Tam, M.D. | Biovail Contract Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioassay Laboratory, Inc. | Houston | Texas | 77099 | United States | ||
| Biovail Contract Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout of 7 Days |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Duricef® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax (Maximum Observed Concentration) | Bioequivalence based on Cmax. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 12 hour period. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | TEVA Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| D002434 | Cefadroxil |
| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Drug |
1 x 500 mg |
|
| Toronto |
| Ontario |
| M1L 4R6 |
| Canada |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on AUC0-t. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 12 hour period. |
|
|
|
|
| Primary | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on AUC0-inf. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 12 hour period. |
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The Principal Investigator is not permitted to discuss or publish trial results.
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |