Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Information source: Pozen
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: celecoxib (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pozen Official(s) and/or principal investigator(s):
Mark Sostek, MD, Study Director, Affiliation: AstraZeneca
Christopher Billings, DO, Principal Investigator, Affiliation: Bio-Kinetic Clinical Applications, LLC
Overall contact:
Christopher Billings, DO, Phone: 417-831-2048, Email: recruiting@bkcaus.com
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
Clinical Details
Official title: Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers
Study design: Other, Randomized, Open Label, Single Group Assignment, Bio-availability Study
Primary outcome: Pharmacokinetics
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Christopher Billings, DO, Phone: 417-831-2048, Email: recruiting@bkcaus.com
Research, Springfield, Missouri, United States; Recruiting
Additional Information
Starting date: July 2008
Ending date: October 2008
Last updated: August 6, 2008
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