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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: Completed Phase 1 study, sponsored by Essentialis.
NCT00688857 is a Phase 1 study that has completed, run by Essentialis. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00688857 record still lists
NCT00688857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Diazoxide choline is the first listed.
NCT00688857 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00688857's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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