Last updated: 11/03/2018 18:41:51

Amoxicillin Bioequivalence Study Brazil - Fast

GSK study ID
115954
See study documents
Clinicaltrials.gov ID
NCT01431989
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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])

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])

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])

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])

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])

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])

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:
Not applicable
Interventions:
Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL
Drug: Amoxil® 500mg/5mL powder for oral suspension
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2011-11-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Bacterial
Product
amoxicillin
Collaborators
Not applicable
Study date(s)
May 2011 to June 2011
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • 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)
  • 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
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Goiania, Goiás, Brazil
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2011-11-06
Actual study completion date
2011-11-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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