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To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946608
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 54 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946608


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946608     History of Changes
Other Study ID Numbers: AA27842
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Antihistamine

Additional relevant MeSH terms:
Loratadine
Antipruritics
Dermatologic Agents
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