Pharmacokinetics Of Celecoxib Test Formulations

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Celebrex capsule; Drug: Test formulation D1; Drug: Test formulation D2; Drug: Test formulation D3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925106

A3191355

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Celebrex capsule

Active Comparator group

Description:

Commercial capsule

Treatment:

Drug: Celebrex capsule

D1

Experimental group

Description:

Test formulation D1

Treatment:

Drug: Test formulation D1

D2

Experimental group

Description:

Test formulation D2

Treatment:

Drug: Test formulation D2

D3

Experimental group

Description:

Test formulation D3

Treatment:

Drug: Test formulation D3