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Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

This study has been completed.
Sponsor:
Collaborator:
Corporación Bonima S.A. de C.V.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01105208
First received: April 12, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

A single dose, two treatments (two cephalexin suspension 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 Intervention Phase
Anti-Infective Agents
 Drug: Cephalexin suspension (Optocef, BAYO5448 )
Drug: Cephalexin suspension (Keflex)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef From Bayer (Cephalexin Suspension 250 mg/5 mL and Equivalent Concentration of Keflex Pediatrico From Eli Lilly (Cephalexin Suspension 125 mg/5mL) in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time at which maximum concentration is reached [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Clearance constant of plasmatic concentrations of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Half life of plasmatic concentration of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: March 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Cephalexin suspension (Optocef, BAYO5448 )
Single dose of 500 mg / 10 mL
Active Comparator: Arm 2 Drug: Cephalexin suspension (Keflex)
Single dose of 500 mg / 20 mL

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 abuse tobacco or alcohol 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105208

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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer de Mexico S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01105208     History of Changes
Other Study ID Numbers: 15188, Biocef-S
Study First Received: April 12, 2010
Last Updated: May 16, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013