Status:
COMPLETED
Amoxicillin Bioequivalence Study Brazil - Fast
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Bacterial
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulati...
Detailed Description
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The objective is to confirm if two formulations of Amoxicillin trihydrate, i...
Eligibility Criteria
Inclusion
- Age between 18 and 50 years
- Body mass index between 18,5 and 25,0, can vary up to 15% for the upper limit (18,5 and 28,75)
- Good health conditions
- Obtain signed informed consent
Exclusion
- Results of laboratory tests outside the normal limits, unless they are considered clinically irrelevant
- The volunteers who underwent surgery or who were hospitalized for any reason before the start of the study will be reviewed by the physician on admission in the study, observing a period of exclusion of 4 to 8 weeks
- Positive test for hepatitis B, hepatitis C or HIV in pre study evaluation
- Known hypersensitivity to the study drug or to compounds chemically related
- Use of experimental drug or participation in any clinical study within 6 months prior to study initiation
- Use of regular medication within 2 weeks prior to study initiation
- History of alcohol or drugs abuse or intake of alcohol within 24 hours prior to the period of confinement
- Consume of inductive drugs and/or enzymatic inhibitors (CYP450 - hepatic), that are toxic for the organism or presenting long half-life's elimination within 30 days prior to study initiation
- Use of MAO and serotonin reuptake inhibitors within 2 weeks prior to study initiation
- Volunteers with psychiatric or psychological illness unless they are considered clinically irrelevant by the investigator
- History or presence of hepatic, renal or gastrointestinal illness or other condition that interferes on drug's absorption, distribution, excretion or metabolism
- History of neurological, endocrine, pulmonary, hematologic, immune, brain, metabolic or cardiovascular illness
- Hypo or hypertension of any etiologic that needs pharmacologic treatment
- History or clinical case of myocardial infarction, angina and/or heart failure
- The volunteer donated or lost 450 mL or more of blood within the 3 months prior to the study initiation
- The volunteer has any condition that obstructs his/her participation in the study according the investigator's judgement
- Smoking
- Positive beta HCG exam for women
- Breastfeeding women
- Women making use of contraceptive medication
Key Trial Info
Start Date :
May 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01431989
Start Date
May 27 2011
End Date
June 11 2011
Last Update
June 20 2018
Active Locations (1)
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1
GSK Investigational Site
Goiânia, Goiás, Brazil