Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-01 @ 1:46 AM
Study NCT ID:
NCT00863902
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2009-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Non-fasting Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2010-08
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:
To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Detailed Description:
Study Type: Interventional Study Design: Single-dose two-way, crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test (Treatment A) and study reference (Treatment B).
Official Title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Official Title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
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?: