To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Phase 1

Completed

• Conditions: Allergy
• Interventions: 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)

• Registration Number: NCT00946608
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

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Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)	Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
2	Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)	Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
3	Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)	Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	54 days