Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 4:26 PM
Study NCT ID:
NCT00778050
Status:
COMPLETED
Last Update Posted:
2008-10-23
First Post:
2008-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 600 mg Amoxicillin Dispersible Tablets vs 400 mg/ 5 mL Amoxil ® for Oral Suspension Under Fasting Conditions.
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: