Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cetero Research, San Antonio | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16). |
|
| B | Experimental | Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazoxide choline | Drug | Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. | 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions | Study days 8 and 16 | |
| Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. | Entire study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan K. Copa, Pharm. D. | PRACS Institute, Ltd. - Cetero Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. - Cetero Research | Fargo | North Dakota | 58104 | United States |
Not provided
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diazoxide choline | Drug | Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily |
|
| D009750 |
| Nutritional and Metabolic Diseases |