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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories); Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913549

239-04

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

Treatment:

Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

2

Experimental group

Description:

Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Treatment:

Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)