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Bioequivalence Study of an Amoxicillin-Clavulanic

Primary Purpose

Infections, Respiratory Tract

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

About this trial

This is an interventional other trial for Infections, Respiratory Tract focused on measuring Mexico, Respiratory infections, Amoxicillin-Clavulanic Acid, Bioequivalence

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A(reference)/B(test)

B(test)/A(reference)

Arm Description

initial administration of reference and cross-over to test

initial administration of test and cross-over to reference

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (CMAX) of Amoxicillin-Clavulanic Acid

Pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of Amoxicillin-Clavulanic Acid

Pharmacokinetics

Secondary Outcome Measures

Full Information

NCT ID

NCT01772238

First Posted

January 17, 2013

Last Updated

August 2, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01772238

Brief Title

Bioequivalence Study of an Amoxicillin-Clavulanic

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 22, 2011 (Actual)

Primary Completion Date

March 30, 2011 (Actual)

Study Completion Date

March 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Respiratory Tract

Keywords

Mexico, Respiratory infections, Amoxicillin-Clavulanic Acid, Bioequivalence

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A(reference)/B(test)

Arm Type

Experimental

Arm Description

initial administration of reference and cross-over to test

Arm Title

B(test)/A(reference)

Arm Type

Experimental

Arm Description

initial administration of test and cross-over to reference

Intervention Type

Drug

Intervention Name(s)

400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

Other Intervention Name(s)

AUGMENTIN 12H suspension GlaxoSmithKline Mexico

Intervention Description

Reference product

Intervention Type

Drug

Intervention Name(s)

400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

Other Intervention Name(s)

AUGMENTIN 12H suspension GlaxoWellcome Production France

Intervention Description

Test product

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (CMAX) of Amoxicillin-Clavulanic Acid

Description

Pharmacokinetics

Time Frame

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

Title

Area under the plasma concentration versus time curve (AUC) of Amoxicillin-Clavulanic Acid

Description

Pharmacokinetics

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Study of an Amoxicillin-Clavulanic

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