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NCT00688857 · ClinicalTrials.gov registry record · Phase 1
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
A Phase 1 study, sponsored by Essentialis.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00688857 is a Phase 1 study that has completed, run by Essentialis. The registered enrollment target is 12 participants.
The verdict
NCT00688857, a Phase 1 study, has completed, sponsored by Essentialis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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
- DRUG Diazoxide choline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-05 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00688857
The ClinicalTrials.gov registry entry for NCT00688857 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Essentialis, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diazoxide choline is the first listed.
NCT00688857 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00688857 about?
NCT00688857 is a clinical study titled "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-rel...
What is the current status of trial NCT00688857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2008-05. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00688857?
The interventions under investigation include: Diazoxide choline (DRUG).
Who is sponsoring clinical trial NCT00688857?
This trial is sponsored by Essentialis, which has 4 total clinical trials registered on ClinicalTrials.gov.
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