To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Drug: 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946608

AA27842

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 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: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Experimental group

Description:

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

Treatment:

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

3

Active Comparator group

Description:

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

Treatment:

Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)