Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729495
• Other study ID #: D1120C00007
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2008
• Last updated: May 12, 2009
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: May 2009
• Source: POZEN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• celecoxib
dose form

Locations

Country	Name	City	State
United States	Research	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
POZEN	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		pre-dose, baseline and multiple times post-dose	No
Secondary	Safety		Throughout study	Yes