To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT00881127
Collaborator
(none)
40
2
Study Details
Study Description
Brief Summary
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions
Study Start Date
:
Jul 1, 2005
Actual Primary Completion Date
:
Jul 1, 2005
Actual Study Completion Date
:
Jul 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA) |
Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)
|
| Active Comparator: 2 Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) |
Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence based on AUC and Cmax [10 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
24 Years
to 54 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
-
Positive test results for HIV or hepatitis B or C.
-
Treatment for drug or alcohol dependence.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sandoz
Investigators
- Principal Investigator: Xueyu (Eric) Chen, M.D., Pharma Medica Research, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00881127
Other Study ID Numbers:
- 2005-983
First Posted:
Apr 15, 2009
Last Update Posted:
Mar 28, 2017
Last Verified:
Apr 1, 2009