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NCT02576353 · ClinicalTrials.gov registry record · Phase 1
Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
A Phase 1 study of Pharmacokinetics and Pharmacodynamics, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02576353: Completed Phase 1 study of Pharmacokinetics and Pharmacodynamics, sponsored by INSYS Therapeutics.
NCT02576353 is a Phase 1 study of Pharmacokinetics and Pharmacodynamics that has completed, run by INSYS Therapeutics. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576353, a Phase 1 study of Pharmacokinetics and Pharmacodynamics, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.
Conditions Studied
Interventions
- DRUG Fentanyl Citrate
- DRUG Fentanyl
Study Locations (1)
California
- Lotus Clinical Research - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-10 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT02576353 record still lists
NCT02576353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Pharmacokinetics and Pharmacodynamics appearing as the primary indexed condition, and to 2 interventions - of which Fentanyl Citrate is the first listed.
NCT02576353 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02576353 about?
NCT02576353 is a clinical study titled "Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects". The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.
What is the current status of trial NCT02576353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2015-10. Estimated completion is 2015-11.
What conditions does trial NCT02576353 study?
This clinical trial studies the following conditions: Pharmacokinetics and Pharmacodynamics.
What interventions are being tested in trial NCT02576353?
The interventions under investigation include: Fentanyl Citrate (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT02576353?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02576353 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02576353's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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