Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions

NCT00778050 | Completed DMC

• 1 other identifier: R02 - 914
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence, amoxicillin 600mg fasting conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited

Drug: Amoxicillin 600mg

2

ACTIVE COMPARATOR

Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals (600mg dose)

Drug: Amoxicillin 600mg

Interventions

Amoxicillin 600mg 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:

• All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing
• The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table
• 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
• 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)

You may not qualify if:

• Volunteers with a recent history of drug or alcohol addiction or abuse
• 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)
• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
• Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen
• Volunteers demonstrating a positive drug abuse screen when screened for this study
• Female volunteers demonstrating a positive pregnancy screen
• Female volunteers who are currently breastfeeding
• Volunteers with a history of allergic response(s) to amoxicillin or related drugs
• Volunteers with a history of clinically significant allergies including drug allergies
• Volunteers with a clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
• Volunteers who currently use tobacco products
• Volunteers who have taken any drug known o induce or inhibit hepatic drug metabolism in the 30 days prior to period I dosing
• 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
• 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
• Volunteers who report receiving any investigational drug within 30 days prior to period I dosing

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

PRACS Institute Ltd.

Fargo, North Dakota, 58104, United States

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: October 1, 2002
• Primary Completion: October 1, 2002
• Study Completion: December 1, 2002
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

US (1)