Bioequivalence Study of an Amoxicillin-Clavulanic

Phase 1

Completed

• Conditions: Infections, Respiratory Tract
• Interventions: Drug: 400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

• Registration Number: NCT01772238
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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 years.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-22
• Primary Completion: 2011-03-30
• Study Completion: 2011-03-30
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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 "Non-clinically significant".

Exclusion Criteria

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 NOM-177-SSA1-1998.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A(reference)/B(test)	400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml	initial administration of reference and cross-over to test
B(test)/A(reference)	400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml	initial administration of test and cross-over to reference

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of Amoxicillin-Clavulanic Acid	0.0, 0.16, 0.33, 0.66, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 5.0, 6.0, and 8.0 postdosage	Pharmacokinetics
Peak Plasma Concentration (CMAX) of Amoxicillin-Clavulanic Acid	0.0, 0.16, 0.33, 0.66, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 5.0, 6.0, and 8.0 postdosage	Pharmacokinetics