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NCT03404817 · ClinicalTrials.gov registry record · Phase 1
Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations
A Phase 1 study, sponsored by Embera NeuroTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03404817 is a Phase 1 study that has completed, run by Embera NeuroTherapeutics. The registered enrollment target is 9 participants.
The verdict
NCT03404817, a Phase 1 study, has completed, sponsored by Embera NeuroTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences
Interventions
- DRUG Original formulation EMB-001
- DRUG New formulation EMB-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03404817
The ClinicalTrials.gov registry entry for NCT03404817 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Embera NeuroTherapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Original formulation EMB-001 is the first listed.
NCT03404817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03404817 about?
NCT03404817 is a clinical study titled "Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations". This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability a...
What is the current status of trial NCT03404817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-03-01. Estimated completion is 2018-06-07.
What interventions are being tested in trial NCT03404817?
The interventions under investigation include: Original formulation EMB-001 (DRUG), New formulation EMB-001 (DRUG).
Who is sponsoring clinical trial NCT03404817?
This trial is sponsored by Embera NeuroTherapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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