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NCT01364558 · ClinicalTrials.gov registry record · Phase 1
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
A Phase 1 study of Epilepsy, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01364558: Completed Phase 1 study of Epilepsy, sponsored by University of Minnesota.
NCT01364558 is a Phase 1 study of Epilepsy that has completed, run by University of Minnesota. The registered enrollment target is 24 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364558, a Phase 1 study of Epilepsy, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
Primary Outcome
To calculate bioavailability we used the following formula: Area Under the Curve (Intranasal Spray)\*100/Area Under the Curve (Intravenous Injection)
Conditions Studied
Interventions
- DRUG Diazepam
Study Locations (1)
Minnesota
- Prism Clinical Research Unit - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01364558 record still lists
NCT01364558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Diazepam is the first listed.
NCT01364558 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01364558 about?
NCT01364558 is a clinical study titled "A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers". The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
What is the current status of trial NCT01364558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-02. Estimated completion is 2011-04.
What conditions does trial NCT01364558 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT01364558?
The interventions under investigation include: Diazepam (DRUG).
Who is sponsoring clinical trial NCT01364558?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01364558 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01364558's enrollment target sits among peer trials
24 123rd of 160 higher than 32 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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.
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