Pharmacokinetics Of Celecoxib Test Formulations

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Celebrex capsule; Drug: Test formulation D1; Drug: Test formulation D3; Drug: Test formulation D2

• Registration Number: NCT00925106
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy male or female volunteers
• Body weight BMI 17.5-30.5

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
• Positive urine drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Celebrex capsule	Celebrex capsule	Commercial capsule
D1	Test formulation D1	Test formulation D1
D3	Test formulation D3	Test formulation D3
D2	Test formulation D2	Test formulation D2

Primary Outcome Measures

Name	Time	Method
AUCinf, AUCt, Cmax	1.5 month
Visual inspection of median plasma concentration versus time profiles resulting from each formulation	1.5 month

Secondary Outcome Measures

Name	Time	Method
adverse events, laboratory tests, vital signs	1.5 month
Tmax, half-life	1.5 month

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States