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To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergies

Intervention: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA) (Drug); Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Xueyu (Eric) Chen, M.D., Principal Investigator, Affiliation: Pharma Medica Research, Inc.

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on AUC and Cmax

Eligibility

Minimum age: 24 Years. Maximum age: 54 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: July 2005
Last updated: April 14, 2009

Page last updated: August 23, 2015

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