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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: Completed Phase 1 study of Healthy, sponsored by Talphera.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the plasma concentration time curve
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 |
What the finished NCT02082236 record still lists
NCT02082236 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02082236's enrollment target sits among peer trials
40 540th of 1090 higher than 513 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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