Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

POZEN

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: celecoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00729495

D1120C00007

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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