Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | March 2011 |
| End Date: | March 2011 |
| Contact: | Gloria C Lin, PhD |
| Email: | gloria.lin@essentialistherapeutics.com |
| Phone: | 858-964-5013 |
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.
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
We found this trial at
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