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| ID | Type | Description | Link |
|---|---|---|---|
| HUPA-HU-1 | Registry Identifier | Haddasah University Hospital |
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| Name | Class |
|---|---|
| Hebrew University of Jerusalem | OTHER |
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The purpose of this study is to develop oral controlled release formulation of Huperzine A that will provide optimal pharmacokinetic profile of the drug enhancing safety and compliance, as possible cure to neurodegenerative disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IR formulation | Active Comparator | Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg) |
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| CR 1 | Experimental | CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg) |
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| CR 2 | Experimental | CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huperzine A | Drug | Each volunteer will receive single dose of three different formulations of Huperzine A. One immediate release formulation of 0.4mg and two different controlled release formulations at same dose. Between the study phases will be a washout period of at least 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of Huperzine A different formulations | Pharmacokinetic parameters: C max, T max, AUC, t1/2 | Blood samples will be taken for 36 hours after Huperzine A administration |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory testing of peripheral AchE inhibition by Huperzine A. Evaluation of adverse events. Laboratory testing of peripheral AchE inhibition by Huperzine A. Evaluation of adverse events. | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Burshtein, MA | Contact | 97226758665/4 | bursht@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Friedman, Proffesor | Institute for Drug Research, Hebrew University of Jerusalem, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah University Hospital | Jerusalem | Israel |
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| ID | Term |
|---|---|
| C050426 | huperzine A |
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