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To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

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ClinicalTrials.gov Identifier: NCT00946608
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : June 2005
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

Eligibility Criteria

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 Posted: July 27, 2009    Key Record Dates
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