A Phase 1 interventional study of Dimebon IR and Dimebon Transdermal in Alzheimer's Disease and Huntington's Disease, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-03.
Sponsored by Pfizer · Phase 1 and Interventional
To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
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This study's enrollment of 19 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Drug: Dimebon IR · Drug: Dimebon Transdermal
Drug: Dimebon IR · Drug: Dimebon Transdermal
A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose in Cohort 1. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data
Time frame: 4 to 6 days
Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs.
Time frame: 4 to 6 days
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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