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Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

NCT ID: NCT00959439

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2002-05-31

Brief Summary

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The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

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Detailed Description

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Conditions

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Rheumatoid Arthritis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

Group Type EXPERIMENTAL

Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

Intervention Type DRUG

2

Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Group Type ACTIVE_COMPARATOR

Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Intervention Type DRUG

Interventions

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Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

Intervention Type DRUG

Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

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

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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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Ronald Goldwater, M.D.

Role: PRINCIPAL_INVESTIGATOR

PharmaKinetics Laboratories Inc.

Other Identifiers

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11704

Identifier Type: -

Identifier Source: org_study_id

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