Recent Updates
Recently added Catalysts

Clemastine

Phase 1

Allergy | Small molecule | Immunology |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Clemastine · 1 trial · 1 indication

Phase 1 1
NCT00913549To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg TabletsAllergy
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Allergy
NCT0091354936
Unlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
19 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALClemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
2EXPERIMENTALTavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Interventions

NameTypeDescription
Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)DRUG -
Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to 55 Years
SexMALE
Healthy VolunteersYes

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.

Unlock Eligibility Criteria