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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00881127
First received: April 13, 2009
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Allergies
Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)
Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

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

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

  Eligibility

Ages Eligible for Study:   24 Years to 54 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00881127

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D. Pharma Medica Research Inc.
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881127     History of Changes
Other Study ID Numbers: 2005-983
Study First Received: April 13, 2009
Last Updated: April 14, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Cetirizine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 28, 2014