Recent Updates
Recently added Catalysts

Loratadine Under Fasting Conditions

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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Loratadine Under Fasting Conditions · 1 trial · 1 indication

Phase 1 1
NCT00946608To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg TabletsAllergy
COMPLETED30 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets
AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
54 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLoratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
2EXPERIMENTALLoratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
3ACTIVE_COMPARATORClaritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Interventions

NameTypeDescription
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 -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 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