Phase 1 Completed N=28 Randomized Other

Amoxicillin Bioequivalence Study Brazil - Fast

Infections, Bacterial

Source: ClinicalTrials.gov NCT01431989 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2012

Primary outcomePrimary: Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t) — 36431.460; 40426.451 ng per hour per ml (ng*hr/mL) — p=0.0000

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)	36431.460; 40426.451	0.0000 sig
PRIMARY Maximum Observed Concentration of Drug Through Time (Cmax)	13615.929; 15176.107	0.0018 sig
PRIMARY Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)	36908.392; 40977.755	0.0000 sig
PRIMARY Time of Maximum Observed Concentration (Tmax)	1.304; 1.482	0.3390
PRIMARY Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)	1.303; 1.353	—
PRIMARY Terminal Half-life (T1/2_Kel)	1.085; 1.137	—
PRIMARY First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)	0.641; 0.620	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01431989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.