Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 10:28 AM
Study NCT ID:
NCT00776334
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2008-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
The Objective of This Study is to Compare the Relative Bioavailability of Fosinopril Sodium 40 mg Tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) With That of Monopril® (Bristol-Myers Squibb, Lot No. 1D47960), in Healthy Adult Subjects 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:
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.
Detailed Description:
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Fosinopril formulations comparing fosinopril 40mg tablets of Ranbaxy Laboratories with Monopril® in healthy, adult, human, subjects under fasting conditions
Eligible subjects underwent pre-study examinations that included a physical examination, 12-1cad ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis C, HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.
Forty (40) subjects were enrolled in this study; 39 completed the study.
Eligible subjects underwent pre-study examinations that included a physical examination, 12-1cad ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis C, HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.
Forty (40) subjects were enrolled in this study; 39 completed 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?: