Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-29 @ 9:07 AM
Study NCT ID:
NCT01283061
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2011-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioavailability Study Of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of 'ACCOLATE' Tablets 20 mg of Astrazeneca Pharmaceuticals, USA In Healthy Adult Human Subjects Under Fasting Conditions.
Status:
COMPLETED
Status Verified Date:
2011-01
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 was to compare the relative bioavailability of zafirlukast tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy, adult, human, subjects under fasting conditions and to monitor safety of subjects.
Detailed Description:
open label, randomized, two-period, two treatment, two sequence, crossover, balanced single dose comparative oral bioavailability study in healthy, adult, human subjects under fasting conditions.44 healthy, adult, human subjects.There was 11-day interval between treatments.
Study Oversight
Has Oversight DMC:
False
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?: