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

This study has been completed.

First Received: April 13, 2009 Last Updated: April 14, 2009 History of Changes

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00881634

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:

Drug Information available for: Cetirizine Cetirizine hydrochloride Pseudoephedrine hydrochloride

U.S. FDA Resources

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	June 2005
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)	Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
2: Active Comparator 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)

Eligibility

Ages Eligible for Study:	20 Years to 53 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881634

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Xueyu (Eric) Chen, M.D.

Pharma Medica Research Inc.

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	2005-984
Study First Received:	April 13, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881634 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Neurotransmitter Agents
Adrenergic Agents
Anti-Asthmatic Agents
Central Nervous System Stimulants
Anti-Allergic Agents
Cardiovascular Agents
Cetirizine
Histamine
Nasal Decongestants
Oxymetazoline

Hypersensitivity
Malnutrition
Histamine Antagonists
Phenylephrine
Vasoconstrictor Agents
Histamine phosphate
Histamine H1 Antagonists
Ephedrine
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nasal Decongestants
Therapeutic Uses
Vasoconstrictor Agents
Pseudoephedrine
Sympathomimetics
Anti-Asthmatic Agents
Histamine Agents
Central Nervous System Stimulants

Cardiovascular Agents
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Ephedrine
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2009