Bioequivalence of Two Commercial Amoxicillin Suspensions
NCT ID: NCT01933698
Last Updated: 2013-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2005-02-28
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Amoxi-Ped
Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast.
amoxicillin
Comparison of pharmacokinetics of both formulations
Amoxil
Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast.
amoxicillin
Comparison of pharmacokinetics of both formulations
Interventions
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amoxicillin
Comparison of pharmacokinetics of both formulations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age between 19 and 46 years
* weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
* ability to provide written consent
* laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
* feeding habits consistent with the standardization of the study
Exclusion Criteria
* history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
* any evidence of dysfunction or clinically significant deviation from normal
* history of any psychiatric illness that might compromise the ability to provide written consent
* history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
* active smoker
* consumption of more than 5 cups of coffee or tea per day
* history of drug dependence or abuse of alcohol consumption
* use of enzymatic-inducers drugs within 30 days or any systemic medication (including prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study
* participation in any clinical study in 9 weeks prior to the study
* have lost or donated more than 350 mL of blood in the last three months
* have been subjected to abnormal diet for any reason (therapeutic, aesthetic, religious, etc.)
* did not have adequate venous access.
19 Years
46 Years
ALL
Yes
Sponsors
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Stiefel, a GSK Company
INDUSTRY
University of Campinas, Brazil
OTHER
Responsible Party
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Francisco Groppo
Full Professor
Principal Investigators
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Francisco C Groppo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Ana PP Cione, Chem.
Role: STUDY_CHAIR
BIOAGRI Laboratórios Ltda
Locations
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BIOAGRI Laboratórios Ltda
Piracicaba, São Paulo, Brazil
Countries
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References
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Baglie S, Rosalen PL, Franco LM, Ruenis AP, Baglie RC, Franco GC, Silva P, Groppo FC. Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers. Int J Clin Pharmacol Ther. 2005 Jul;43(7):350-4. doi: 10.5414/cpp43350.
Other Identifiers
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63.064.653/0001-54
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AMOXIPED-01
Identifier Type: -
Identifier Source: org_study_id