Trial | NCT00688857  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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.
Study Started
May 31
2008
Primary Completion
Jun 30
2008
Study Completion
Jul 31
2008
Last Update
Nov 07
2010
Estimate

Drug Diazoxide choline

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

Drug Diazoxide choline

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

A Experimental

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).

B Experimental

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)

Criteria 

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
No Results Posted