Pharmacokinetics Of Celecoxib Test Formulations

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Celebrex capsuleDRUG

Single dose 200 mg commercial Celebrex capsule

Test formulation D1DRUG

Single dose 150 mg celecoxib as formulation D1

Test formulation D2DRUG

Single dose 150 mg celecoxib as formulation D2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

AUCinf, AUCt, Cmax

Time frame: 1.5 month

Visual inspection of median plasma concentration versus time profiles resulting from each formulation

Time frame: 1.5 month

Secondary Outcomes

Tmax, half-life

Time frame: 1.5 month

adverse events, laboratory tests, vital signs

Time frame: 1.5 month

Data from ClinicalTrials.gov

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