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To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

NCT ID: NCT00946608

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

2

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

3

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Gaetano Morelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Early Clinical Research

Other Identifiers

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AA27842

Identifier Type: -

Identifier Source: org_study_id

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