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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00881127
Other study ID # 2005-983
Secondary ID
Status Completed
Phase Phase 1
First received April 13, 2009
Last updated March 27, 2017
Start date July 2005
Est. completion date July 2005

Study information

Verified date April 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 54 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)

Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sandoz

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 10 days
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