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A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Kalamazoo, Michigan, 49007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Huntington's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Subjects must have either a CYP2D6 EM (n=12) or PM (n=12) status based on genotyping
at screening.

- Subjects must have a CYP2C19 EM status based on status at screening.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.

- Subjects with any history of a previous seizure or convulsion or significant head
trauma.

- Subjects specifically allergic to imidazole antifungal agents.

- Subjects specifically allergic to omeprazole or other proton pump inhibitors.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- Subjects with hypersensitivity reactions to Dimebon or other antihistamines.

- Consumption of grapefruit or grapefruit containing products within 7 days prior to the
first dose of study medication.

- Subjects currently taking omeprazole, other proton pump inhibitors, antacids,
H2-blockers or CYP2C19 inhibitors.

- Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of nonhormonal contraception as outlined in this
protocol from at least 14 days prior to the first dose of study medication.

NCT00931073
Pfizer
Completed
A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers

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[email protected]

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