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To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946608
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.


Condition Intervention Phase
Allergy
 Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Sandoz Inc. and Schering (Claritin) 10 mg Loratadine Tablets In Healthy Adult Male Volunteers Under Fed and Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Loratadine
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 54 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
 Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
Experimental: 2
Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
 Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
Active Comparator: 3
Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)
 Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
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: NCT00946608

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Gaetano Morelli, M.D. Early Clinical Research
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946608     History of Changes
Other Study ID Numbers: AA27842
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antihistamine

Additional relevant MeSH terms:
Loratadine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
 Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013