Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

marketed celecoxib

Group Type ACTIVE_COMPARATOR

celecoxib

Intervention Type DRUG

dose form

2

overencapsulated celecoxib

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

dose form

Interventions

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celecoxib

dose form

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria

* Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes