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Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

NCT00901823 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-09-01

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Diazoxide choline

A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR

DRUG

Diazoxide choline high dose

A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Sponsors & Collaborators

  • Essentialis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901823 on ClinicalTrials.gov