Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fed Conditions - Full Text View

Sponsored by:	Ranbaxy Laboratories Limited
Information provided by:	Ranbaxy Inc.
ClinicalTrials.gov Identifier:	NCT00778284

Purpose

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions

Condition	Intervention
Healthy	Drug: Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg Amoxicillin (as the Trihydrate)/57 mg Clavulanic Acid (as the Potassium Salt) Chewable Tablets in Healthy Adult Volunteers Following Administration of a Two Tablet Dose Under Fed Conditions

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:

Bioequivalence [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	October 2002
Study Completion Date:	December 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets of Ranbaxy	Drug: Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets
2: Active Comparator Augumentin chewable tablets of Glaxosmithkline	Drug: Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets

Detailed Description:

The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin® 40o mg) amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions A total of 40 Subjects, 20 males and 20 females; were enrolled in the study, and 39 subjects, 20 males and 19 females, completed the study.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult male or female volunteers, 18-55 years of age
Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
Medically healthy subjects with clinically normal laboratory profiles;
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; barrier methods (condom, diaphragm) with spermicide for at least 14 days pror to the start of the study and .throughout the study; surgical sterilization of the partner (vasectomy for 6 months minimum); hormonal contraceptives for at least 3 months pdor to the start of the study. Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible;
Voluntarily consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of:

alcoholism or drug abuse within the past 2 years; hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid
Female subjects who are pregnant or lactating.
Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose.
Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study.
Subjects who have made a plasma donation within 7 days prior to the study
Subjects who have participated in another clinical trial within 30 days prior to the first dose.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778284

Locations

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044

Sponsors and Collaborators

Ranbaxy Laboratories Limited

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ranbaxy Research Labs ( Dr. Tausif monif )
Study ID Numbers:	AA02873
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778284 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:

Bioequivalence

Study placed in the following topic categories:

Anti-Bacterial Agents
Amoxicillin
Malnutrition
Clavulanic Acid

Clavulanic Acids
Healthy
Amoxicillin-Potassium Clavulanate Combination

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Clavulanic Acid
Clavulanic Acids
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009