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NCT01761565 · ClinicalTrials.gov registry record · Phase 1
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
A Phase 1 study of Plasma Concentrations, sponsored by Talphera.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01761565: Completed Phase 1 study of Plasma Concentrations, sponsored by Talphera.
NCT01761565 is a Phase 1 study of Plasma Concentrations that has completed, run by Talphera. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01761565, a Phase 1 study of Plasma Concentrations, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Single dose of SUF NT 15 mcg
- DRUG 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Study Locations (1)
Kansas
- PRA - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT01761565 record still lists
NCT01761565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Plasma Concentrations appearing as the primary indexed condition, and to 2 interventions - of which Single dose of SUF NT 15 mcg is the first listed.
NCT01761565 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01761565 about?
NCT01761565 is a clinical study titled "Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab". Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
What is the current status of trial NCT01761565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2013-01. Estimated completion is 2013-02.
What conditions does trial NCT01761565 study?
This clinical trial studies the following conditions: Plasma Concentrations.
What interventions are being tested in trial NCT01761565?
The interventions under investigation include: Single dose of SUF NT 15 mcg (DRUG), 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes (DRUG).
Who is sponsoring clinical trial NCT01761565?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01761565 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01761565's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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