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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Anti-Infective Agents Drug: Cephalexin capsules (Optocef, BAYO5448 ) Drug: Cephalexin capsules (Keflex) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Cephalexin capsules (Optocef, BAYO5448 )
Single dose of 500 mg (One 500 mg capsule)
Active Comparator: Arm 2 Drug: Cephalexin capsules (Keflex)
Single dose of 500 mg (Two 250 mg capsules)


Outcome Measures

Primary Outcome Measures :
  1. Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After two months ]
  2. Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After two months ]

Secondary Outcome Measures :
  1. Time at which maximum concentration is reached [ Time Frame: After two months ]
  2. Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two months ]
  3. Clearance constant of plasmatic concentration of study drug [ Time Frame: After two months ]
  4. Half life of plasmatic concentration of study drug [ Time Frame: After two months ]
  5. Adverse events collection [ Time Frame: Up to six weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

  • History of illnesses or any organic abnormalities that could affect the results of the study
  • History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
  • Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
Contacts and Locations

Information from the National Library of Medicine

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): NCT01073553


Locations
Mexico
Morelia, Michoacán, Mexico, 58256
Sponsors and Collaborators
Bayer
Corporación Bonima S.A. de C.V.
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01073553     History of Changes
Other Study ID Numbers: 14784
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents