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pharmacokinetic interaction

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Aug 7, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

pharmacokinetic interaction clinical trials

pharmacokinetic interaction · 1 trial · 1 indication

Phase 1 1
NCT00369304Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and SubstrateHealthy Subjects
COMPLETED- Analytics
PHASE1COMPLETED
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
pharmacokinetic (how the body absorbs and eliminates) interactionDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes

1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included. 2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg. 3. Healthy as determined by the investigator on the basis of medical history, physical examination,...

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Frequently asked questions about pharmacokinetic interaction

What is the pharmacokinetic interaction studied by Pfizer?

It is a Phase 1 study evaluating how the body absorbs and eliminates a drug when a CYP2C9 inhibitor is given with a CYP2C9 substrate. The trial examined the potential drug interaction between these two agents in healthy adult subjects. Pfizer, Inc. conducted the research under NCT00369304.

What is the pharmacokinetic interaction used for?

The pharmacokinetic interaction study was designed to characterize how a CYP2C9 inhibitor affects the absorption and elimination of a CYP2C9 substrate. It was conducted in healthy volunteers rather than in patients with a specific disease, so it does not have a therapeutic indication. The trial is complete.

Who makes the pharmacokinetic interaction study drug?

Pfizer, Inc. (ticker PFE) is the developer of the pharmacokinetic interaction study. The company sponsored the Phase 1 trial NCT00369304, which evaluated the potential drug interaction between a CYP2C9 inhibitor and a CYP2C9 substrate in healthy subjects.

What phase is the pharmacokinetic interaction study in?

The pharmacokinetic interaction study is a Phase 1 trial, and it has been completed. It was an uncontrolled, randomized study conducted in healthy volunteers aged 18 years and older. No active trials of this pharmacokinetic interaction are currently listed.

What clinical trials is the pharmacokinetic interaction in?

The pharmacokinetic interaction was evaluated in one completed Phase 1 trial, NCT00369304, titled Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate. The trial enrolled healthy volunteers, was randomized, and used an uncontrolled design without blinding.