Clinical trial NCT01933698: Bioequivalence of Two Commercial Amoxicillin Suspensions
Official title: Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bioequivalence of Amoxicillin
Keywords: Bioequivalence
Amoxicillin
Human
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Stiefel, a GSK Company
First posted: 2013-09-02
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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.

Primary outcomes:
measure: Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
timeFrame: Change from baseline to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: BIOAGRI Laboratórios Ltda
state: SP
Study officials:
affiliation: University of Campinas, Brazil
name: Francisco C Groppo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BIOAGRI Laboratórios Ltda
name: Ana PP Cione, Chem.
role: STUDY_CHAIR
References:
citation: 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.