Bioequivalence of Two Commercial Amoxicillin Suspensions
Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioequivalence of Amoxicillin
Intervention: amoxicillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Campinas, Brazil Official(s) and/or principal investigator(s): Francisco C Groppo, PhD, Principal Investigator, Affiliation: University of Campinas, Brazil Ana PP Cione, Chem., Study Chair, Affiliation: BIOAGRI Laboratórios Ltda
Summary
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the
bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian
volunteers.
Clinical Details
Official title: Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
Detailed description:
Under fasting condition, 25 volunteers (13 males and 12 females) were included in this
randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study.
Blood samples were collected at pre-dose (0h) and 0. 5, 1, 1. 33, 1. 66, 2, 2. 5, 3, 4, 6, 8 and
12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2,
Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations
for both formulations in each subject.
Eligibility
Minimum age: 19 Years.
Maximum age: 46 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy
test for women
- 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:
- pregnancy
- 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.
Locations and Contacts
BIOAGRI Laboratórios Ltda, Piracicaba, SP 13412-000, Brazil
Additional Information
Related publications: 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.
Starting date: February 2005
Last updated: August 28, 2013
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