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Amoxicillin Bioequivalence Study Brazil - Fast

Primary Purpose

Infections, Bacterial

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

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

Amoxil® 500mg/5mL powder for oral suspension

About this trial

This is an interventional other trial for Infections, Bacterial

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Test formulation

Reference formulation

Arm 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.

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

Outcomes

Primary Outcome Measures

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)

The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.

Maximum Observed Concentration of Drug Through Time (Cmax)

Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method).

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)

Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.

Time of Maximum Observed Concentration (Tmax)

The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.

Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)

The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.

Terminal Half-life (T1/2_Kel)

T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.

First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)

This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.

Secondary Outcome Measures

Full Information

NCT ID

NCT01431989

First Posted

September 8, 2011

Last Updated

June 18, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01431989

Brief Title

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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

May 27, 2011 (Actual)

Primary Completion Date

June 11, 2011 (Actual)

Study Completion Date

June 11, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Bacterial

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test formulation

Arm Type

Active Comparator

Arm Description

Arm Title

Reference formulation

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Test formulation

Intervention Type

Drug

Intervention Name(s)

Amoxil® 500mg/5mL powder for oral suspension

Intervention Description

Reference formulation

Primary Outcome Measure Information:

Title

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)

Description

Time Frame

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])

Title

Maximum Observed Concentration of Drug Through Time (Cmax)

Description

Time Frame

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])

Title

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)

Description

Time Frame

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])

Title

Time of Maximum Observed Concentration (Tmax)

Description

Time Frame

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])

Title

Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)

Description

Time Frame

Title

Terminal Half-life (T1/2_Kel)

Description

T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.

Time Frame

Title

First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Goiania

State/Province

Goiás

Country

Brazil

12. IPD Sharing Statement

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