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Amoxicillin Bioequivalence Study Brazil - Fast

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ClinicalTrials.gov Identifier: NCT01431989
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : February 7, 2012
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Infections, Bacterial Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL Drug: Amoxil® 500mg/5mL powder for oral suspension Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 27, 2011
Actual Primary Completion Date : June 11, 2011
Actual Study Completion Date : June 11, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Test formulation
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
Test formulation
Active Comparator: Reference formulation
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
Reference formulation



Primary Outcome Measures :
  1. Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t) [ 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]) ]
    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.

  2. Maximum Observed Concentration of Drug Through Time (Cmax) [ 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]) ]
    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).

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

  4. Time of Maximum Observed Concentration (Tmax) [ 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]) ]
    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.

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

  6. Terminal Half-life (T1/2_Kel) [ 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]) ]
    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.

  7. First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel) [ 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]) ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431989


Locations
Brazil
GSK Investigational Site
Goiania, Goiás, Brazil
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431989     History of Changes
Other Study ID Numbers: 115954
First Posted: September 12, 2011    Key Record Dates
Results First Posted: February 7, 2012
Last Update Posted: May 22, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Bacterial Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents