Expired Study
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Phoenix, Arizona 85044


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


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Healthy adult male or female volunteers, 18-55 years of age 2. 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); 3. Medically healthy subjects with clinically normal laboratory profiles; 4. 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; 5. 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: 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. 2. 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 3. Female subjects who are pregnant or lactating. 4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose. 5. 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. 6. Subjects who have made a plasma donation within 7 days prior to the study 7. Subjects who have participated in another clinical trial within 30 days prior to the first dose.


Study is Available At:


Original ID:

AA02873


NCT ID:

NCT00778284


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fed Conditions


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 Follo


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ranbaxy Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Study Dates

Start Date:October 2002
Completion Date:December 2002
Completion Type:Actual
Primary Completion Date:October 2002
Primary Completion Type:Actual
Verification Date:October 2008
Last Changed Date:October 22, 2008
First Received Date:October 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Amoxicillin 400mg + clovalunic acid 57.5mg chewabl
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets of Ranbaxy
Study Arm Type:Active Comparator
Arm Name:2
Description:Augumentin chewable tablets of Glaxosmithkline

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ranbaxy Laboratories Limited

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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