Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS

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.

Inclusion Criteria:

• Signed informed consent
• Healthy adults
• Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
• Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria:

• Known CAD, DM, uncontrolled HTN
• Pregnancy or unable to complaint with the birth control method required