To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Phase 1CompletedNCT00913549

Sandoz36 enrolled

Overview

To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergy

Interventions

Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)DRUG

Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)DRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 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: 19 days

Data from ClinicalTrials.gov

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