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The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences:
(A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KT110 | Experimental | Subjects will be randomized to receive KT110 on period 1 or period 2 |
|
| Prazosin + cyproheptadine | Experimental | Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazosin + cyproheptadine | Drug | Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) 0-t | Area under the curve from time 0 to the last measurable concentration at time t | Day 4 |
| AUC 0-inf | Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine) | Day 4 |
| Cmax | Maximum observed concentration | Day 4 |
| Tmax | Time of maximum observed concentration | Day 4 |
| T1/2 | Apparent elimination half-life | Day 4 |
| K el | Apparent Elimination rate constant | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | 38610 | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| D003533 | Cyproheptadine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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open-label, randomized, 2-period, single dose, crossover study
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| KT110 | Drug | Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization. |
|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |