To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Phase 1CompletedNCT00946608

Sandoz30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergy

Interventions

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)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 54 days

Data from ClinicalTrials.gov

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