Pharmacokinetics Of Celecoxib Test Formulations

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00925106
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 4
• Duration (Months): 1
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Celebrex capsule; Drug: Test formulation D1; Drug: Test formulation D2; Drug: Test formulation D3	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Celebrex capsule Commercial capsule	Drug: Celebrex capsule; Single dose 200 mg commercial Celebrex capsule
Experimental: D1 Test formulation D1	Drug: Test formulation D1; Single dose 150 mg celecoxib as formulation D1
Experimental: D2 Test formulation D2	Drug: Test formulation D2; Single dose 150 mg celecoxib as formulation D2
Experimental: D3 Test formulation D3	Drug: Test formulation D3; Single dose 150 mg celecoxib as formulation D3

Outcome Measures

Primary Outcome Measures

1. AUCinf, AUCt, Cmax [1.5 month]

2. Visual inspection of median plasma concentration versus time profiles resulting from each formulation [1.5 month]

Secondary Outcome Measures

1. Tmax, half-life [1.5 month]

2. adverse events, laboratory tests, vital signs [1.5 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511-5473

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00925106
• Other Study ID Numbers: A3191355
• First Posted: Jun 19, 2009
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Bioavailability, pharmacokinetics, celecoxib
• Additional relevant MeSH terms: Celecoxib

Study Results

No Results Posted as of Feb 2, 2021