Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
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ClinicalTrials.gov Identifier: NCT01761565 |
Recruitment Status :
Completed
First Posted : January 7, 2013
Results First Posted : February 11, 2015
Last Update Posted : October 1, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plasma Concentrations | Drug: Single dose of SUF NT 15 mcg Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
Drug: Single dose of SUF NT 15 mcg Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes Other Name: Zalviso™ |
- Cmax [ Time Frame: 24 hours in Treatment A, 37 hours in Treatment B ]
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1.
For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
- Time to Steady State [ Time Frame: 24 hours ]Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)
- CST½ [ Time Frame: 24 ]the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Non smoking
- Ages 18 to 45 year, inclusive
- BMI between 18 and 30
Exclusion Criteria:
- Subjects taking any prescription or OTC medications or vitamins or supplements
- Pregnant females
- Subjects with pulmonary disease or sleep apnea

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761565
United States, Kansas | |
PRA | |
Lenexa, Kansas, United States, 66219 |
Principal Investigator: | Sandra K. Willsie, D.O. | PRA |
Responsible Party: | AcelRx Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01761565 |
Other Study ID Numbers: |
IAP101 |
First Posted: | January 7, 2013 Key Record Dates |
Results First Posted: | February 11, 2015 |
Last Update Posted: | October 1, 2015 |
Last Verified: | September 2015 |