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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01073540
First received: February 22, 2010
Last updated: April 1, 2014
Last verified: April 2014
  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 Suspension 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

Resource links provided by NLM:


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 concentration 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: September 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073540

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01073540     History of Changes
Other Study ID Numbers: 14783
Study First Received: February 22, 2010
Last Updated: April 1, 2014
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 April 23, 2014