Amoxicillin Bioequivalence Study Brazil - Fast

• Status: Completed
• Trial end date: 2011-06-11
• Target enrollment: 0
• Participant gender: All

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 formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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