Bioequivalence Study of an Amoxicillin-Clavulanic
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Respiratory Tract
Intervention: 400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml (Drug); 400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml (Drug)
Phase: Phase 1
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
The objective of this study was to confirm if two formulations of amoxicillin and clavulanic
acid (suspension) are bioequivalent.
Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo
Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg
Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.
The study was prospective, open-label, randomized, crossover, single dose, with 02
treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 35 healthy volunteers, both genders, adults between 18-50
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.
Official title: Bioequivalence Study of an Amoxicillin-Clavulanic Acid Suspension Preparation. Cross-over, Randomized, Single Dose, Two Treatments, Two Periods and Two Sequences Trial in Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Peak Plasma Concentration (CMAX) of Amoxicillin-Clavulanic Acid
Area under the plasma concentration versus time curve (AUC) of Amoxicillin-Clavulanic Acid
Minimum age: 18 Years.
Maximum age: 45 Years.
Both genders. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26
kg/m2. Anti-doping tests negative results. Females with negative pregnancy tests Clinical
biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose,
Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins,
Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase, Lactic
Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac
VIH, AgsHB and RPR (luetic test), must fall within an interval between minimum and maximum
values in connection to said tests accepted values.
Normal Electrocardiogram and Chest X-rays. In exception cases, accepted may be a candidate
for which any previously mentioned test is exceeded regarding considered valid maximum and
minimum accepted normal values, as long as it involves an isolated value and there are no
other manifestations which could allow assuming that a given value is related to a disease
or is remnant of another. These cases must be approved by clinical area and declared as
Biochemistry, Electrocardiographic Radiological Anomalies; Anti-doping tests positive
results, Positive results regarding RPR; VIH and AgsHB tests. Personal or family history
of allergy to medication in question. Having any kind of allergy, since these persons are
in higher risk of suffering from medicamentous allergy.
Tobacco use. Recreational drug use. Persons undergoing any medical treatment. Existence of
concurrent or intercurrent disease. Existence of justified doubt regarding questionnaire
answers truthfulness. Having participated in bioequivalence or bioavailability studies or
having donated blood 2 months before the study.
Presence of clinically important gastrointestinal diseases or malabsorption history during
the last year.
Presence of a medical condition requiring regular medication (with prescription or
over-the- counter medication) with systemic absorption.
Narcotics or alcohol addiction history requiring treatment. Finally, excluded will be all
those volunteers not meeting that established in Mexican Official Standard
Locations and Contacts
Starting date: March 2011
Last updated: January 17, 2013