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A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers

NCT00813241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-02-02

No results posted yet for this study

Summary

A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation.

Conditions

  • Healthy Volunteers

Interventions

DRUG

celecoxib reference formulation

200 mg single oral dose of celecoxib tablets

DRUG

celecoxib test formulation A1

150 mg single oral dose of celecoxib A1 formulation tablets

DRUG

celecoxib test formulation B2

150 mg single oral dose of celecoxib B2 formulation tablets

DRUG

celecoxib test formulation C1

150 mg single oral dose of celecoxib Cl formulation tablets

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813241 on ClinicalTrials.gov