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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688857

Enrollment

Registered

2008-06-03

Start date

2008-05-31

Completion date

2008-07-31

Last updated

2010-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Brief summary

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.

Interventions

DRUGDiazoxide choline

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.	16 days

Secondary

Measure	Time frame
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions	Study days 8 and 16
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.	Entire study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026