Clinical Trials/NCT00946608

NCT00946608

Completed

Phase 1

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

Sandoz0 sites30 target enrollmentStarted: June 2005Last updated: March 28, 2017

ConditionsAllergy

InterventionsLoratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

DrugsLoratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Overview

Phase: Phase 1
Status: Completed
Sponsor: Sandoz
Enrollment: 30
Primary Endpoint: Bioequivalence based on AUC and Cmax

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Overview

Brief Summary

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

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

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.

Arms & Interventions

1

Experimental

Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)

Intervention: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) (Drug)

2

Experimental

Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)

Intervention: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) (Drug)

3

Active Comparator

Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Intervention: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) (Drug)

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time Frame: 54 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Sponsor Class

Industry

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