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A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00857571
Enrollment
12
Registered
2009-03-06
Start date
2009-04-30
Completion date
2009-05-31
Last updated
2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Dose Response Bioavailability Study

Brief summary

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Interventions

DRUG30 mg Suspension

Single oral dose of 30 mg of PF-02413873 suspension

DRUG150 mg Suspension

Single oral dose of 150 mg of PF-02413873 suspension

DRUG400 mg Suspension

Single oral dose of 400 mg of PF-02413873 suspension

DRUG5 mg Suspension

Single oral dose of 5 mg of PF-02413873 suspension

DRUG750 mg Suspension

Single oral dose of 750 mg of PF-02413873 suspension

DRUG150 mg Tablet

Single oral dose of 150 mg of PF-02413873 tablets

DRUG30 mg Tablet

Single oral dose of 30 mg of PF-02413873 tablets

DRUG400 mg Tablet

Single oral dose of 400 mg of PF-02413873 tablets

DRUG5 mg Tablet

Single oral dose of 5 mg of PF-02413873 tablets

DRUG750 mg Tablet

Single oral dose of 750 mg of PF-02413873 tablets

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male and female volunteers. * Female volunteers have to be of non-childbearing potential

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy). * A positive urine drug screen.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics: Cmax, AUCinfJune - July 2009

Secondary

MeasureTime frame
Tmax, Tlag, AUClast, AUCt, t½, Frel.June-July 2009

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026