To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Sandoz Inc. and Schering (Claritin) 10 mg Loratadine Tablets In Healthy Adult Male Volunteers Under Fed and Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00946608

Enrollment

Registered

2009-07-27

Start date

2005-06-30

Completion date

2005-08-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Antihistamine

Brief summary

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

Interventions

DRUGLoratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)

DRUGLoratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)

DRUGClaritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	54 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026