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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778284
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


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
Experimental: 1
Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets of Ranbaxy
Drug: Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets
Active Comparator: 2
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Ranbaxy Inc.:
Bioequivalence

Additional relevant MeSH terms:
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014