Amoxicillin Bioequivalence Study Brazil - Fast

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Infections, Bacterial

Treatments: Drug: Amoxil® 500mg/5mL powder for oral suspension; Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431989

115954

Details and patient eligibility

About

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.

Full 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, in the form powder for oral suspension, are bioequivalent. The test product is Amoxicillin trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the form powder for oral suspension and reference product is Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the form of powder for oral suspension. Twenty eight healthy volunteers, of both genders, were evaluated. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions. In each period blood samples are collected in the following times: 0.00 (prior to administration of medication); 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 (after administration of medication). The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Test formulation

Active Comparator group

Description:

Test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 1; followed by 14-days washout period during which no medication was administered; followed by reference product: Amoxil® 500mg/5mL in Period 2.

Treatment:

Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL

Reference formulation

Active Comparator group

Description:

Reference product: Amoxil® 500mg/5mL powder for oral suspension in Period 1; followed by 14-days washout period during which no medication was administered; followed by test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 2

Treatment:

Drug: Amoxil® 500mg/5mL powder for oral suspension