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NCT03996694 · ClinicalTrials.gov registry record · Phase 1
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
A Phase 1 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03996694 is a Phase 1 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 19 participants.
The verdict
NCT03996694, a Phase 1 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
Interventions
- DRUG Belbuca 300 µg
- DRUG Belbuca 600 µg
- DRUG Belbuca 900 µg
- DRUG Oxycodone 30 mg
- DRUG Oxycodone 60 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2019-10-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996694
The ClinicalTrials.gov registry entry for NCT03996694 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Belbuca 300 µg is the first listed.
NCT03996694 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03996694 about?
NCT03996694 is a clinical study titled "Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.". The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreati...
What is the current status of trial NCT03996694?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-07-23. Estimated completion is 2019-10-27.
What interventions are being tested in trial NCT03996694?
The interventions under investigation include: Belbuca 300 µg (DRUG), Belbuca 600 µg (DRUG), Belbuca 900 µg (DRUG), Oxycodone 30 mg (DRUG), Oxycodone 60 mg (DRUG).
Who is sponsoring clinical trial NCT03996694?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
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