NCT00925106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

June 18, 2009

Last Update Submit

January 29, 2021

Conditions

Healthy Volunteers

Keywords

Bioavailability, pharmacokinetics, celecoxib

Outcome Measures

Primary Outcomes (2)

  • AUCinf, AUCt, Cmax

    1.5 month

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

    1.5 month

Secondary Outcomes (2)

  • Tmax, half-life

    1.5 month

  • adverse events, laboratory tests, vital signs

    1.5 month

Study Arms (4)

Celebrex capsule

ACTIVE COMPARATOR

Commercial capsule

Drug: Celebrex capsule

D1

EXPERIMENTAL

Test formulation D1

Drug: Test formulation D1

D2

EXPERIMENTAL

Test formulation D2

Drug: Test formulation D2

D3

EXPERIMENTAL

Test formulation D3

Drug: Test formulation D3

Interventions

Celebrex capsuleDRUG

Single dose 200 mg commercial Celebrex capsule

Celebrex capsule
Test formulation D1DRUG

Single dose 150 mg celecoxib as formulation D1

D1
Test formulation D2DRUG

Single dose 150 mg celecoxib as formulation D2

D2
Test formulation D3DRUG

Single dose 150 mg celecoxib as formulation D3

D3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

US(1)