Trial Outcomes & Findings for A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling (NCT NCT07223450)
NCT ID: NCT07223450
Last Updated: 2026-05-06
Results Overview
Area under the curve from 0 time to the last measurable concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
up to 24 hours
Results posted on
2026-05-06
Participant Flow
From June 2025 to October 2025, participants were recruited from the Clinical Research Unit database of the Hospital Mar Research Institute.
Participant milestones
| Measure |
Group A: Intranasal - Oral
Intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
|
Group B: Oral-Intranasal
Oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=8 Participants
Healthy adult participants enrolled in this randomized crossover study evaluating oral and intranasal administration of oxycodone.
|
|---|---|
|
Age, Customized
|
34.8 Years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
|
Body Mass Index
|
25.0 kg/m^2
STANDARD_DEVIATION 2.6 • n=8 Participants
|
PRIMARY outcome
Timeframe: up to 24 hoursArea under the curve from 0 time to the last measurable concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group: Oral
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
AUC(0-24h)
|
7373.6 ng·min/mL
Standard Deviation 1954.6
|
7195.7 ng·min/mL
Standard Deviation 1824.8
|
PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseTime of maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group: Oral
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
Tmax
|
40 min
Interval 10.0 to 180.0
|
50 min
Interval 30.0 to 60.0
|
PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseThe mean maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations
Outcome measures
| Measure |
Group: Oral
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
Cmax
|
24.0 ng/mL
Standard Deviation 5.9
|
26.6 ng/mL
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Up to 24 hoursAE was performed including number and percentage.
Outcome measures
| Measure |
Group: Oral
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
Adverse Effects (AE)
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24 hoursTo assess the effects of oxycodone on pupil size; only results at 24 hours will be reported.
Outcome measures
| Measure |
Group: Oral
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
Pupil Diameter
|
3.5 mm
Standard Deviation 0.9
|
3.2 mm
Standard Deviation 0.6
|
Adverse Events
Group: Oral
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group: Intranasal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group: Oral
n=8 participants at risk
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
Group: Intranasal
n=8 participants at risk
Participants were randomized to one of two treatment sequences:
* Sequence A: oral oxycodone in Period 1 followed by intranasal oxycodone in Period 2.
* Sequence B: intranasal oxycodone in Period 1 followed by oral oxycodone in Period 2.
Results are presented by treatment received.
|
|---|---|---|
|
Nervous system disorders
Vertigo
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours.
|
0.00%
0/8 • From Day 1 to End of Study, up to 24 hours.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours.
|
0.00%
0/8 • From Day 1 to End of Study, up to 24 hours.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From Day 1 to End of Study, up to 24 hours.
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours.
|
Additional Information
Ana Mª Aldea Perona
Hospital del Mar Research Institute
Phone: (+34) 93 316 04 90
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place