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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 is a Phase 1 study of Pharmacokinetics and Pharmacodynamics that has completed, run by INSYS Therapeutics. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.

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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.

Interventions

  • DRUG Fentanyl Citrate
  • DRUG Fentanyl

Study Locations (1)

California

  • Lotus Clinical Research - Pasadena

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2015-10
Est. Completion 2015-11
Phase Phase 1

Sponsor

INSYS Therapeutics

35 total trials

What the Registry Record Tells You About NCT02576353

The ClinicalTrials.gov registry entry for NCT02576353 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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