Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT02138396 |
Recruitment Status :
Completed
First Posted : May 14, 2014
Last Update Posted : December 12, 2014
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Condition or disease | Intervention/treatment | Phase |
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Bioavailability | Drug: Fentanyl Sublingual Spray (FSS) Drug: Fentanyl Citrate Injection (FCI) Drug: Naltrexone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
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Experimental: FSS first, then FCI
At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single dose of fentanyl sublingual spray (FSS) at the first visit. After a washout period of at least seven days, they receive a single intramuscular fentanyl citrate injection (FCI) at the second treatment visit.
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Drug: Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Other Name: Subsys® Drug: Fentanyl Citrate Injection (FCI) A single dose of fentanyl citrate, 100 mcg per intramuscular injection Drug: Naltrexone Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl. |
Experimental: FCI first, then FSS
At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single intramuscular fentanyl citrate injection (FCI) at the first visit. After a washout period of at least seven days, they receive a single dose of fentanyl sublingual spray (FSS) at the second treatment visit.
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Drug: Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Other Name: Subsys® Drug: Fentanyl Citrate Injection (FCI) A single dose of fentanyl citrate, 100 mcg per intramuscular injection Drug: Naltrexone Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl. |
- Maximum concentration (Cmax) by mode of administration [ Time Frame: within 36 hours after dosing ]
- Area under the concentration-time curve [AUC(last)] by mode of administration [ Time Frame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose ]
- Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration [ Time Frame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception
- Good access to veins on both sides
- Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria:
- Intolerance to venipuncture or injections
- Presence or history of oral disease, irritation or piercings
- Allergy or adverse response to fentanyl, naltrexone, or related drugs
- Tattoos, scarring, or other skin abnormality at planned injection sites
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138396
United States, Texas | |
Worldwide Clinical Trials Early Phase Services, LLC | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | George J Atiee, MD | Worldwide Clinical Trials Early Phase Services, LLC |
Responsible Party: | INSYS Therapeutics Inc |
ClinicalTrials.gov Identifier: | NCT02138396 |
Other Study ID Numbers: |
INS-13-019 |
First Posted: | May 14, 2014 Key Record Dates |
Last Update Posted: | December 12, 2014 |
Last Verified: | December 2014 |
Fentanyl Naltrexone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents |
Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics Alcohol Deterrents Narcotic Antagonists |