Pharmacokinetics Of Celecoxib Test Formulations

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Celebrex capsule

Commercial capsule

Group Type ACTIVE_COMPARATOR

Celebrex capsule

Intervention Type DRUG

Single dose 200 mg commercial Celebrex capsule

D1

Test formulation D1

Group Type EXPERIMENTAL

Test formulation D1

Intervention Type DRUG

Single dose 150 mg celecoxib as formulation D1

D2

Test formulation D2

Group Type EXPERIMENTAL

Test formulation D2

Intervention Type DRUG

Single dose 150 mg celecoxib as formulation D2

D3

Test formulation D3

Group Type EXPERIMENTAL

Test formulation D3

Intervention Type DRUG

Single dose 150 mg celecoxib as formulation D3

Interventions

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Celebrex capsule

Single dose 200 mg commercial Celebrex capsule

Intervention Type DRUG

Test formulation D1

Single dose 150 mg celecoxib as formulation D1

Intervention Type DRUG

Test formulation D2

Single dose 150 mg celecoxib as formulation D2

Intervention Type DRUG

Test formulation D3

Single dose 150 mg celecoxib as formulation D3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female volunteers
* Body weight BMI 17.5-30.5

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Positive urine drug screen

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes