Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
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ClinicalTrials.gov Identifier: NCT00688857 |
Recruitment Status :
Completed
First Posted : June 3, 2008
Last Update Posted : November 7, 2010
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Condition or disease | Intervention/treatment | Phase |
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Hypertriglyceridemia | Drug: Diazoxide choline | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A
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).
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Drug: Diazoxide choline
Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily |
Experimental: B
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)
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Drug: Diazoxide choline
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily |
- Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. [ Time Frame: 16 days ]
- Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions [ Time Frame: Study days 8 and 16 ]
- Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. [ Time Frame: Entire study ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed informed consent
- Healthy male and female subjects 18 to 75 years of age
- Body mass index (BMI) between 22-35 kg/m2
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
- Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
- Not pregnant
Exclusion Criteria:
- Significant underlying medical conditions
- Clinical laboratory test values outside the accepted range
- Smokers, tobacco users, or subjects currently using nicotine products
- Substance abuse
- History of allergic response(s) to diazoxide or related drugs
- Recent significant weight loss
- Use of medication affecting body weight, lipid or glucose metabolism
- Unable to comply with study procedures

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688857
United States, North Dakota | |
PRACS Institute, Ltd. - Cetero Research | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | Alan K. Copa, Pharm. D. | PRACS Institute, Ltd. - Cetero Research |
Responsible Party: | Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc |
ClinicalTrials.gov Identifier: | NCT00688857 |
Other Study ID Numbers: |
PK008 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | November 7, 2010 |
Last Verified: | November 2010 |
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Diazoxide Choline Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents Antihypertensive Agents Vasodilator Agents |