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NCT02082236 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
A Phase 1 study of Healthy, sponsored by Talphera.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02082236 is a Phase 1 study of Healthy that has completed, run by Talphera. The registered enrollment target is 40 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02082236, a Phase 1 study of Healthy, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.
Conditions Studied
Interventions
- DRUG Treatment Arm A: Sufenta®
- DRUG Treatment B: Sufentanil SSM 30 mcg
- DRUG Treatment C: SSM 15 mcg
- DRUG Treatment D: SSM 30 mcg
Study Locations (1)
Kansas
- PRA - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02082236
The ClinicalTrials.gov registry entry for NCT02082236 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Treatment Arm A: Sufenta® is the first listed.
NCT02082236 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT02082236 about?
NCT02082236 is a clinical study titled "Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects". The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.
What is the current status of trial NCT02082236?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-05. Estimated completion is 2014-05.
What conditions does trial NCT02082236 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02082236?
The interventions under investigation include: Treatment Arm A: Sufenta® (DRUG), Treatment B: Sufentanil SSM 30 mcg (DRUG), Treatment C: SSM 15 mcg (DRUG), Treatment D: SSM 30 mcg (DRUG).
Who is sponsoring clinical trial NCT02082236?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02082236 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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