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

NCT ID: NCT00688857

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Diazoxide choline

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Diazoxide choline

Intervention Type DRUG

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

Interventions

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Diazoxide choline

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

Intervention Type DRUG

Diazoxide choline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cetero Research, San Antonio

NETWORK

Sponsor Role collaborator

Essentialis, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Essentialis, Inc

Principal Investigators

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Alan K. Copa, Pharm. D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute, Ltd. - Cetero Research

Locations

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PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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PK008

Identifier Type: -

Identifier Source: org_study_id