Clinical trial NCT01431989: Amoxicillin Bioequivalence Study Brazil - Fast
Official title: Evaluation of Pharmaceutical Bioequivalence of Amoxicillin Trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the Form Powder for Oral Suspension Versus Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the Form of Powder for Oral Suspension in Healthy Volunteers and Fasting, Using Techniques of Liquid Chromatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Bacterial
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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, 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.

Eligibility 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

Primary outcomes:
measure: Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)
timeFrame: Collection points (hours [hrs]): 0.00; 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 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: Maximum Observed Concentration of Drug Through Time (Cmax)
timeFrame: Collection points (hrs): 0.00; 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 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)
timeFrame: Collection points (hrs):0.00; 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 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: Time of Maximum Observed Concentration (Tmax)
timeFrame: Collection points (hrs):0.00; 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 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)
timeFrame: Collection points (hrs):0.00; 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 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: Terminal Half-life (T1/2_Kel)
timeFrame: Collection points (hrs):0.00; 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 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
measure: First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)
timeFrame: Collection points (hrs):0.00; 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 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: GSK Investigational Site
state: Goiás
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: