Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00835081|
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Cefadroxil 500 mg Capsules Drug: DURICEF® capsules 500 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two-Way , Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefadroxil 500 mg Capsules Versus DURICEF® 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
Drug: Cefadroxil 500 mg Capsules
1 x 500 mg
|Active Comparator: 2||
Drug: DURICEF® capsules 500 mg
1 x 500 mg
- Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ]Bioequivalence based on Cmax.
- AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ]Bioequivalence based on AUC0-t.
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ]Bioequivalence based on AUC0-inf.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835081
|United States, Texas|
|Bioassay Laboratory, Inc.|
|Houston, Texas, United States, 77099|
|Biovail Contract Research|
|Toronto, Ontario, Canada, M1L 4R6|
|Principal Investigator:||Paul Y Tam, M.D.||Biovail Contract Research|