NCT00959439

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_1 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

August 13, 2009

Last Update Submit

March 27, 2017

Conditions

Rheumatoid ArthritisOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    55 days

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

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

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

Interventions

Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)DRUG
1
Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)DRUG
2

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Interventions

Naproxen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ronald Goldwater, M.D.

    PharmaKinetics Laboratories Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

March 1, 2002

Primary Completion

May 1, 2002

Study Completion

May 1, 2002

Last Updated

March 28, 2017

Record last verified: 2017-03