CLINICAL TRIALS PROFILE FOR DIAZOXIDE CHOLINE
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All Clinical Trials for diazoxide choline
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00688857 ↗ | Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations | Completed | Cetero Research, San Antonio | Phase 1 | 2008-05-01 | 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. |
| NCT00688857 ↗ | Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations | Completed | Essentialis, Inc. | Phase 1 | 2008-05-01 | 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. |
| NCT00696475 ↗ | Diazoxide Choline in Hypertriglyceridemia | Completed | Medpace, Inc. | Phase 2 | 2008-06-01 | Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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