Amoxicillin Bioequivalence Study Brazil - Fast

NCT01431989 | Completed Phase 1 Results

• 1 other identifier: 115954
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Bacterial

Outcome Measures

Primary Outcomes (7)

• 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.

  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])

• 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).

  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])

• 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.

  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])

• 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.

  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])

• 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%.

  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])

• 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.

  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])

• 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.

  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])

Study Arms (2)

Test formulation

ACTIVE COMPARATOR

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.

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

Reference formulation

ACTIVE COMPARATOR

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

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

Interventions

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

Test formulation

Test formulation

Amoxil® 500mg/5mL powder for oral suspension DRUG

Reference formulation

Reference formulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Results of laboratory tests outside the normal limits, unless they are considered clinically irrelevant
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Goiânia, Goiás, Brazil

Location

Related Links

• Results for study 115954 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Bacterial Infections

Interventions

Suspensions; Amoxicillin; Powders

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 12, 2011
• Study Start: May 27, 2011
• Primary Completion: June 11, 2011
• Study Completion: June 11, 2011
• Last Updated: June 20, 2018
• Results First Posted: February 7, 2012

Record last verified: 2018-06

Locations

BR (1)