Effect of Delivery Route on PK of Sufentanil NanoTab

Study Overview
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Brief Summary
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Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Official Title
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Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Treatment A: Sufentanil IV
* Drug: Treatment B: Sufentanil NanoTab Sublingual
* Drug: Treatment C: Sufentanil NanoTab Buccal
* Drug: Treatment D: Sufentanil NanoTab Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index 18 - 30 Exclusion Criteria: pregnant females smokers pulmonary disease sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 - Treatment A, B, C, D<br>15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|
| Experimental: Sequence 2 - Treatment A, B, D, C<br>15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|
| Experimental: Sequence 3 - Treatment A, C, B, D<br>15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|
| Experimental: Sequence 4 - Treatment A, C, D, B<br>15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|
| Experimental: Sequence 5 - Treatment A, D, B, C<br>15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|
| Experimental: Sequence 6 - Treatment A, D, C, B<br>15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual | Drug: Treatment A: Sufentanil IV<br>* Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)<br>Drug: Treatment B: Sufentanil NanoTab Sublingual<br>* Single Sufentanil NanoTab 15 mcg given sublingually (SL)<br>Drug: Treatment C: Sufentanil NanoTab Buccal<br>* Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)<br>Drug: Treatment D: Sufentanil NanoTab Oral<br>* Single Sufentanil NanoTab 15 mcg swallowed (PO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0 - Inf) | total amount of sufentanil absorbed | 24 hours | 
| Cmax | maximum plasma concentration | 24 hours | 
| Tmax | time to maximum plasma concentration | 24 hours | 
| CST 1/2 | time for maximum plasma concentration to decrease by 50% | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, area under curve, time to maximum concentration