Clinical trials: Fentanyl
- Drug or intervention Fentanyl
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Pharmacokinetics and Pharmacodynamics
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.
- Trial name
- NCT02576353
- Testing
- Fentanyl, Fentanyl Citrate
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Fentanyl Overdose, Fentanyl Poisoning
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of…
- Trial name
- NCT07459166
- Testing
- Naloxone Hydrochloride, Fentanyl, Sterile Saline
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Clear Scientific, Inc.
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Pain, Postoperative
Pharmacokinetic Characterization of the Active, Separated System With PK Controller (Fentanyl Iontophoretic Transdermal System, 40 Mcg Fentanyl Per Activation).
"This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence design. A total of 54 eligible subjects will receive three total treatments; one with intravenous (IV) infusion and two with the Study…
- Trial name
- NCT01750060
- Testing
- Fentanyl, Naltrexone
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Incline Therapeutics, Inc.
Personality
Personality and Drug Use (PDU)
The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and…
- Trial name
- PDU (NCT05180149)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Quantified Citizen Technologies Inc.
Biological Availability
Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers
The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of fentanyl following oral administration.
- Trial name
- NCT00714558
- Testing
- Fentanyl citrate; Naltrexone; Naloxone
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Pain
Relative Bioavailability of a Fentanyl Patch
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.
- Trial name
- NCT00857753
- Testing
- Fentanyl patch 25 ug/nr Sandoz, Duragesic
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy, Opioid Use
Buprenorphine-Fentanyl Interaction Study
An increase in overdose deaths has been attributed to widespread access to fentanyl and carfentanyl. The study is designed to determine if buprenorphine can change the respiratory depression response to intravenous (IV) fentanyl.
- Trial name
- NCT03747341
- Testing
- Buprenorphine Injectable Solution - Part A, Fentanyl - Part A, Ondansetron - Parts A + B
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Pain
Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)
The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.
- Trial name
- NCT01780233
- Testing
- Fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, Fentanyl citrate injection 100 µg intravenously
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy
Study Evaluating Inhaled AeroLEF Delivered in 4 Aerosol Delivery Devices in Healthy Volunteers
This was an open-label, two-phase, crossover, safety, pharmacokinetic (PK), and pharmacodynamic (PD) study in normal, healthy, non-smoking, fasting male and female subjects. The first phase (A.
- Trial name
- LEF-07 (NCT00794209)
- Testing
- i.v fentanyl, AeroLEF
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- YM BioSciences
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Healthy
Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
- Trial name
- NCT02617758
- Testing
- Fentanyl
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.
- Trial name
- NCT01717157
- Testing
- Treatment A: DUROGESIC (8.4 mg fentanyl), Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Pharmacology
Fentanyl Sublingual Spray in Opioid Naive Participants
The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants.
- Trial name
- NCT02641340
- Testing
- Fentanyl Sublingual Spray, Fentanyl Citrate IV
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc.
- Trial name
- NCT00650117
- Testing
- Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M), Duragesic 25 mcg/h + Scotch Duct Tape (3M), Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Chronic Pain
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
- Trial name
- NCT00650182
- Testing
- fentanyl; naltrexone
- Volunteers
- 406 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following…
- Trial name
- NCT00647842
- Testing
- Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioavailability
Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.
- Trial name
- NCT02138396
- Testing
- Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI), Naltrexone
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy
Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects
This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device.
- Trial name
- LEF-2495 (NCT00709254)
- Testing
- i.v. fentanyl, 3 mL AeroLEF (500 µg/1 mL)
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- YM BioSciences