A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
NCT00990613
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- Caucasian, male or females, 50 to 85 years inclusive.
- Subjects must have adequate space available on each side of the upper or middle back that is free from excessive hair, broken or irritated skin, tattoos, scars, moles, acne, and sunburn.
- Evidence or history of any major medical or psychiatric illness or unstable medical
condition within six months of Screening that may increase the risk associated with
study participation.
- Subjects with any central nervous system disease including Alzheimer's disease,
Parkinson's disease, Huntington disease, or any form of dementia.
- Subjects with any history of stroke, known cerebrovascular disease or subjects with
any history of structural brain disease.
- Any history of epilepsy, seizure disorder (i.e., including febrile seizures) or
convulsion.
- Subjects with any skin disorders that might prevent application of the dimebon
solution including, but not limited to, any known sensitivity to adhesives.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin | |||
Official Title ICMJE | A Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older Adults | |||
Brief Summary | To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Chew ML, Mordenti J, Yeoh T, Ranade G, Qiu R, Fang J, Liang Y, Corrigan B. Minimization of CYP2D6 Polymorphic Differences and Improved Bioavailability via Transdermal Administration: Latrepirdine Example. Pharm Res. 2016 Aug;33(8):1873-80. doi: 10.1007/s11095-016-1922-4. Epub 2016 Apr 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 19 | |||
Original Estimated Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | January 2010 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00990613 | |||
Other Study ID Numbers ICMJE | B1451038 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Medivation, Inc. | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |