Clinical trials: Fentanyl
Healthy
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
- Trial name
- NCT00864565
- Testing
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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
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
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
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.
Pain
Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.
The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.
- Trial name
- NCT01173627
- Testing
- Test fentanyl citrate 400 mcg troche, Actiq 400 mcg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl
A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.
- Trial name
- NCT02470390
- Testing
- Fentanyl
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Depomed
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
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
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
Pain, Postoperative
Bioequivalence Between Integrated E-TRANS (Fentanyl) System and Separated (Two-Part) E-TRANS (Fentanyl) System
The purpose of this study is to confirm that the two forms of the device the Integrated E-TRANS (fentanyl HCl) system and the Separated (Two-Part) E-TRANS (fentanyl HCl) System provide the equivalent blood levels of medication…
- Trial name
- NCT00990418
- Testing
- Separated (Two Part) E-TRANS (fentanyl HCl) System; Integrated E-TRANS (fentanyl HCl) System
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
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
General Anesthesia
Exploratory Study of Propofol and Fentanyl Pharmacodynamics
Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.
- Trial name
- NCT01550770
- Testing
- propofol
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery
Healthy
A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants
The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
- Trial name
- NCT02608320
- Testing
- Duragesic (Fentanyl Transdermal System [TDS] Small Patches), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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 the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc.
- Trial name
- NCT00648414
- Testing
- Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1, Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2, Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals 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
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay
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
- NCT00647686
- Testing
- Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals 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
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.