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The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic | Other | This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic | Drug | Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Levels of Drug | This is the plasma level of the drug as determined by high performance liquid chromatography. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Freedman, MD | VA Eastern Colorado Health Care System, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Eastern Colorado Health Care System, Denver | Denver | Colorado | 80220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacokinetic | This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This is a collection of volunteers from the health science community who responded to approved advertisements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacokinetic | This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years as determine by asking the subject when their birthdate is. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Levels of Drug | This is the plasma level of the drug as determined by high performance liquid chromatography. | This is all participants in the study. | Posted | Mean | Standard Deviation | ng/ml | 12 hours |
|
|
Adverse events were collected for 24 hours.
Subjects were questioned every hour for 8 hours and then 24 later, after administration of drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacokinetic | This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Freedman | University of Colorado | 3037244940 | Robert.Freedman@ucdenver.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000071184 | Pharmacogenomic Variants |
| C088936 | 3-(2,4-dimethoxybenzylidene)anabaseine |
| ID | Term |
|---|---|
| D011110 | Polymorphism, Genetic |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This is gender or sex as determined by inquiry from the subjects | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | We ask the subjects to report their ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | This is the area from which all the subjects come. | Number | participants |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
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