This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: March 27, 2017
Last verified: July 2009
  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: No masking
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 24, 2009
Last Updated: March 27, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017