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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002549-37 | EudraCT Number | ||
| U1111-1135-2623 | Registry Identifier | WHO |
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The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (A-B-C) | Experimental |
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| Sequence 2 (A-C-B) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFS (Intranasal Fentanyl Spray) | Drug | Intranasal Fentanyl Spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] | AUC= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from simulated single dose concentration time profiles derived from the final parameters of the PopPK model [clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)]. | Blood sampling for PK will be performed until 72 hours after the first treatment administration |
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Eligibility Criteria:
Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational Site | Mannheim | 68157 | Germany |
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