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Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy Subjects

NCT00831506•Pfizer

View on ClinicalTrials.gov

Summary

This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a sensitive P-gp substrate recommended by FDA.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
•Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

•A known history of hypersensitivity or previous intolerance to Dimebon or digoxin.
•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) disease or clinical findings at screening.
•Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

June 12, 2009

Enrollment

ACTUAL participants

Conditions

Alzheimer DiseaseHuntington Disease

Interventions

digoxin

DRUG

digoxin

DRUG

dimebon

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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