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OpenTrials
Completed

NCT Number: NCT00688857

Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazoxide choline

Drug

Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions

    Time frame: Study days 8 and 16

  2. Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.

    Time frame: Entire study

Sponsors and collaborators

Lead sponsor

Essentialis, Inc.

Industry

Collaborators

  • Cetero Research, San Antonio

Registry information

Official study title

A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Nov 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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