- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946608
To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets
March 27, 2017 updated by: Sandoz
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
To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
|
|
Experimental: 2
Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
|
|
Active Comparator: 3
Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on AUC and Cmax
Time Frame: 54 days
|
54 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaetano Morelli, M.D., Early Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (Estimate)
July 27, 2009
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA27842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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