Trial · NCT02531971

Fentanyl Patch Pharmacokinetics in Healthy Adults

NCT02531971, Phase 4, Completed, University of Maryland, Baltimore; results first posted 2020-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fentanyl Patch Pharmacokinetics in Healthy Adults. Trials, record NCT02531971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02531971

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fentanyl Patch Pharmacokinetics in Healthy Adults
NCT number: NCT02531971
Status: Completed
Phases: Phase 4
Enrollment: 24 participants, actual
Lead sponsor: University of Maryland, Baltimore
Conditions: Peer Review, Research
Interventions: Intravenous fentanyl citrate, Duragesic®, Mylan generic fentanyl
First posted: 2015-08-25
Last updated: 2020-03-26
Results first posted: 2020-03-26

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Area Under the Curve (AUC 0-∞ ) ng∙h/mL	10 procedure days for Duragesic and Mylan arms each	drug concentration in serum vs. time; reflects the actual body exposure to drug after administration of a dose of the drug

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Area Under the Curve (AUC 0-∞ ) ng∙h/mL	10 procedure days for Duragesic and Mylan arms each	Reported values are for all 24 volunteers.	ng∙h/mL	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Area Under the Curve (AUC 0-∞ ) ng∙h/mL	Duragesic		60.1	Standard Deviation 31.6	ng∙h/mL
Area Under the Curve (AUC 0-∞ ) ng∙h/mL	Mylan		64.2	Standard Deviation 35.1	ng∙h/mL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fentanyl Citrate (36 h), Duragesic® (192 h), Mylan (192 h)	11
Overall Study	STARTED	Fentanyl Citrate (36 h), Mylan (192 h), Duragesic® (192 h)	13
Overall Study	COMPLETED	Fentanyl Citrate (36 h), Duragesic® (192 h), Mylan (192 h)	11
Overall Study	COMPLETED	Fentanyl Citrate (36 h), Mylan (192 h), Duragesic® (192 h)	13
Overall Study	NOT COMPLETED	Fentanyl Citrate (36 h), Duragesic® (192 h), Mylan (192 h)	0
Overall Study	NOT COMPLETED	Fentanyl Citrate (36 h), Mylan (192 h), Duragesic® (192 h)	0

Source ClinicalTrials.gov

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Product Issues	Fentanyl Citrate	4	24	4
other	Nausea	Product Issues	Duragesic®	2	24	2
other	Nausea	Product Issues	Mylan Generic Fentanyl	2	24	2
other	Decreased heart rate	Product Issues	Fentanyl Citrate	10	24	20
other	Decreased heart rate	Product Issues	Duragesic®	13	24	53
other	Decreased heart rate	Product Issues	Mylan Generic Fentanyl	13	24	49
other	Increased heart rate	Product Issues	Fentanyl Citrate	2	24	2
other	Increased heart rate	Product Issues	Duragesic®	0	24	0
other	Increased heart rate	Product Issues	Mylan Generic Fentanyl	4	24	4
other	Increased blood pressure	Product Issues	Fentanyl Citrate	5	24	6

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fentanyl Citrate	0	24
Total, all-cause mortality	Duragesic®	0	24
Total, all-cause mortality	Mylan Generic Fentanyl	0	24
Total, other adverse events	Fentanyl Citrate	24	24
Total, other adverse events	Duragesic®	24	24
Total, other adverse events	Mylan Generic Fentanyl	24	24
Total, serious adverse events	Fentanyl Citrate	0	24
Total, serious adverse events	Duragesic®	0	24
Total, serious adverse events	Mylan Generic Fentanyl	0	24

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02531971

GET https://conductscience.org/api/trials/v1/NCT02531971/events?page=2

API reference For AI assistants