Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg - 42.9 mg/ 5 mL Oral Suspension Under Fasting Conditions

NCT00778414 | Completed DMC

• 1 other identifier: 60249
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence Amoxicillin Clavulanic acid 600mg 42.9 mg per 5 mL oral suspension

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension of ranbaxy

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

2

ACTIVE COMPARATOR

Augmentin ES - 600

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Interventions

Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension DRUG

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, SFBC Anapharm Web site, SFBC Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:
• Male or female, smoker or non - smoker, 18 years of age or older
• Capable of consent
• BMI should be greater than, or equal to 19.0 and less than 30.0

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illness or surgery within 4 weeks prior to dosing
• Any clinically significant abnormality or abnormal laboratory test results found during medical screening
• Any reason which, in the opinion of the Clinical Sub - Investigator, would prevent the subjects from participating in the study
• Positive test for hepatitis B, hepatitis C or HIV at screening
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening
• History of significant alcohol abuse or drug abuse within one year prior to the screening
• Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[ 1 unit = 150 mL of wine, 360 mL of beer, 0r 45 mL of 40% alcohol\])
• Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening
• History of allergic reactions to amoxicillin - clavulanic acid, penicillin, or other related drugs
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, Omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolines, antihistamines) within 30 days prior to administration of the study medication
• Use of an investigational drug or participation in an investigational study within 30 days prior to dosing
• Clinically significant history or presence of any gastrointestinal pathology (e.g.: chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g.: diarrhea, vomiting) liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
• Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease
• Use of the prescription medication within 14 days prior to the administration of study medication or over - the - counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to the administration of the study medication, except for topical products without systemic absorption and hormonal contraceptives

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Anapharm

Québec, Quebec, G1V2K8, Canada

Location

Related Links

• Related Info
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MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Suspensions

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

CA (1)