Back to resultsTo Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Primary Purpose
Allergies
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Sponsored by
About this trial
This is an interventional treatment trial for Allergies
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00881634
Brief Title
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Official Title
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Intervention Type
Drug
Intervention Name(s)
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
Intervention Type
Drug
Intervention Name(s)
Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueyu (Eric) Chen, M.D.
Organizational Affiliation
Pharma Medica Research, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
We'll reach out to this number within 24 hrs