Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
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ClinicalTrials.gov Identifier: NCT01073553 |
Recruitment Status
:
Completed
First Posted
: February 23, 2010
Last Update Posted
: April 3, 2015
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Sponsor:
Bayer
Collaborator:
Corporación Bonima S.A. de C.V.
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | February 22, 2010 | |||
First Posted Date ICMJE | February 23, 2010 | |||
Last Update Posted Date | April 3, 2015 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01073553 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules | |||
Official Title ICMJE | Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations | |||
Brief Summary | A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anti-Infective Agents | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
26 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01073553 | |||
Other Study ID Numbers ICMJE | 14784 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Corporación Bonima S.A. de C.V. | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |