Bioequivalence Clinical Trial
Official title:
Open-label, Randomized, Crossover, Two-period, Two-sequence, Single-center, Comparative Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.
The objective of this study is to establish if two formulations of amoxicillin + clavulanic
acid combination are bioequivalent. Also monitoring, registration and evaluation of adverse
events will be performed. The test formulation is Clavamox, powder for oral suspension, 400
mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus). The reference formulation is Augmentin®,
powder for oral suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia).
56 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will
be divided into two cohorts with equal number of subjects (28). Each subject in a cohort will
receive single dose (5 ml containing 400 mg of amoxicillin and 57 mg of clavulanic acid) of
the test or the reference formulation with 200 ml of water after an overnight fast of at
least 10 hours, according to the pre-defined randomization list, i. e. 14 subjects in each
cohort will receive the test product and 14 subjects in each cohort will receive the
reference product. Subjects will fast 4 hours after administration of the study drugs during
each study period. Standardized meals will be provided in each study period. Water will not
be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours
after administration of the study drugs in each period.
In each period blood samples will be collected before dosing and 0.25, 0.5, 0.75, 1.00, 1.25,
1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after
dosing (total number: 19). The washout period is 7 days.
A validated HPLC/MS/MS method will be used to determine plasma concentrations of two analytes
(amoxicillin and clavulanic acid).
ANOVA will be performed on log-transformed pharmacokinetic parameters Cmax, AUC0-t and 90%
confidence interval will be constructed for the ratio of geometric least square means of the
test and the reference products, obtained from the log-transformed data. Bioequivalence will
be concluded if the ratio estimate as well as its 90% confidence interval for each analyte,
both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.
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