Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778050
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

This study compared the relative bioavailability (rate and extent of absorption) of amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals following single oral dose (600 mg) in healthy, adult, subjects under fasting conditions using a randomized two-way crossover design.


Condition Intervention
Healthy
Drug: Amoxicillin 600mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 600 mg Amoxicillin Dispersible Tablets vs 400 mg/ 5 mL Amoxil ® for Oral Suspension Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 26
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 tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited
Drug: Amoxicillin 600mg
Active Comparator: 2
Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals (600mg dose)
Drug: Amoxicillin 600mg

Detailed Description:

A single oral dose of the test or reference product was administered to volunteers on two separate occasions under fasting conditions with at least a 7 day washout between the doses. Twenty-six healthy volunteers were randomly assigned to the test or the reference products. Food and fluid intake were controlled during each confinement period.

Twenty six (26) healthy subjects (16 males and 10 females) were enrolled in the study, of which 25 subjects completed the clinical phase of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing
  2. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table
  3. Each volunteer will complete a screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures
  4. If female and:

    • of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
    • is postmenopausal for at least 1 year; or
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  1. Volunteers with a recent history of drug or alcohol addiction or abuse
  2. Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)
  3. Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
  4. Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen
  5. Volunteers demonstrating a positive drug abuse screen when screened for this study
  6. Female volunteers demonstrating a positive pregnancy screen
  7. Female volunteers who are currently breastfeeding
  8. Volunteers with a history of allergic response(s) to amoxicillin or related drugs
  9. Volunteers with a history of clinically significant allergies including drug allergies
  10. Volunteers with a clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
  11. Volunteers who currently use tobacco products
  12. Volunteers who have taken any drug known o induce or inhibit hepatic drug metabolism in the 30 days prior to period I dosing
  13. Volunteers who report donating greater than 150 mL of blood within 30 days prior to period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study
  14. Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study
  15. Volunteers who report receiving any investigational drug within 30 days prior to period I dosing
  16. Volunteers who report taking any systemic prescription medication in the 14 days prior to period I dosing.
  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: NCT00778050

Locations
United States, North Dakota
PRACS Institute Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00778050     History of Changes
Other Study ID Numbers: R02 - 914
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence, amoxicillin 600mg fasting conditions

Additional relevant MeSH terms:
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014