To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946608
• Other study ID #: AA27842
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2009
• Last updated: March 27, 2017
• Start date: June 2005
• Est. completion date: August 2005

Study information

• Verified date: July 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)

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

• Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		54 days