Healthy Volunteer
Conditions
Keywords
Phase I,, Healthy, Volunteer, Study
Brief summary
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
Interventions
DRUGcelecoxib
dose form
Sponsors
AstraZeneca
POZEN
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | pre-dose, baseline and multiple times post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Safety | Throughout study |
Countries
United States
Outcome results
None listed