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Did not support the planned development of DCCR in the new indication
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This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR |
|
| Sequence 2 | Experimental | Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazoxide choline | Drug | A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions | 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Diazoxide choline high dose | Drug | A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR |
|
| D009750 |
| Nutritional and Metabolic Diseases |