Trial Outcomes & Findings for Fentanyl Patch Pharmacokinetics in Healthy Adults (NCT NCT02531971)
NCT ID: NCT02531971
Last Updated: 2020-03-26
Results Overview
drug concentration in serum vs. time; reflects the actual body exposure to drug after administration of a dose of the drug
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
10 procedure days for Duragesic and Mylan arms each
Results posted on
2020-03-26
Participant Flow
Participant milestones
| Measure |
Fentanyl Citrate (36 h), Duragesic® (192 h), Mylan (192 h)
Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples were obtained for 0-36 h, washout at least one week, then same volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples were obtained for 0-192 h, washout at least one week, then same volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session IIII) and blood samples obtained for 0-192 h
|
Fentanyl Citrate (36 h), Mylan (192 h), Duragesic® (192 h)
Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples obtained for 0-36 h, washout at least one week, then same volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples obtained for 0-192 h, washout at least one week, then same volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session IIII) and blood samples were obtained for 0-192 h
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fentanyl Patch Pharmacokinetics in Healthy Adults
Baseline characteristics by cohort
| Measure |
Fentanyl Citrate, Then Duragesic®, Then Mylan
n=11 Participants
Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I), washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (Study Session II), washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session III)
|
Fentanyl Citrate, Then Mylan, Then Duragesic®
n=13 Participants
Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I), washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session II), washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (Study Session III)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 procedure days for Duragesic and Mylan arms eachPopulation: Reported values are for all 24 volunteers.
drug concentration in serum vs. time; reflects the actual body exposure to drug after administration of a dose of the drug
Outcome measures
| Measure |
Duragesic
n=24 Participants
Volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (either Study Session II or Study Session III)
|
Mylan
n=24 Participants
Volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session II or Study Session III)
|
|---|---|---|
|
Area Under the Curve (AUC 0-∞ ) ng∙h/mL
|
60.1 ng∙h/mL
Standard Deviation 31.6
|
64.2 ng∙h/mL
Standard Deviation 35.1
|
Adverse Events
Fentanyl Citrate
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Duragesic®
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Mylan Generic Fentanyl
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fentanyl Citrate
n=24 participants at risk
Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I); blood samples obtained from 0-36 h
|
Duragesic®
n=24 participants at risk
Volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (either Study Session II or Study Session III); blood samples obtained from 0-192 h
|
Mylan Generic Fentanyl
n=24 participants at risk
Volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (either Study Session II or Study Session III); blood samples obtained from 0-192 h
|
|---|---|---|---|
|
Product Issues
Nausea
|
16.7%
4/24 • Number of events 4 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
8.3%
2/24 • Number of events 2 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
8.3%
2/24 • Number of events 2 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Decreased heart rate
|
41.7%
10/24 • Number of events 20 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
54.2%
13/24 • Number of events 53 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
54.2%
13/24 • Number of events 49 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Increased heart rate
|
8.3%
2/24 • Number of events 2 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
0.00%
0/24 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
16.7%
4/24 • Number of events 4 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Increased blood pressure
|
20.8%
5/24 • Number of events 6 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
25.0%
6/24 • Number of events 22 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
20.8%
5/24 • Number of events 10 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Decreased blood pressure
|
4.2%
1/24 • Number of events 2 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
25.0%
6/24 • Number of events 21 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
33.3%
8/24 • Number of events 21 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Headache
|
16.7%
4/24 • Number of events 4 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
20.8%
5/24 • Number of events 7 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
8.3%
2/24 • Number of events 3 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Decreased respiratory rate
|
25.0%
6/24 • Number of events 6 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
12.5%
3/24 • Number of events 7 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
12.5%
3/24 • Number of events 3 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Increased respiratory rate
|
62.5%
15/24 • Number of events 27 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
75.0%
18/24 • Number of events 39 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
45.8%
11/24 • Number of events 31 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Abdominal cramping
|
0.00%
0/24 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
0.00%
0/24 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
8.3%
2/24 • Number of events 2 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Investigations
Pain, swelling, bruising, abrasions, erythema at IV catheter site
|
0.00%
0/24 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
12.5%
3/24 • Number of events 3 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
12.5%
3/24 • Number of events 3 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
|
Product Issues
Erythema
|
4.2%
1/24 • Number of events 1 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
12.5%
3/24 • Number of events 3 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
16.7%
4/24 • Number of events 4 • 25 days (study duration); any adverse events were followed up until resolved
All adverse events were category 3 (other, not serious); all were expected adverse events according to package inserts
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place