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NCT01639729
Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects
Phase 1 trial testing Treatment A: Sufentanil IV in Pharmacokinetics in 25 participants. Completed in 1 July 2012.
1 July 2012
Quick facts
| Lead sponsor | Talphera, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 25 |
| Start date | 1 July 2012 |
| Primary completion | 1 July 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Treatment A: Sufentanil IV — full drug profile →
- Treatment B: Sufentanil NanoTab Sublingual — full drug profile →
- Treatment C: Sufentanil NanoTab Buccal — full drug profile →
- Treatment D: Sufentanil NanoTab Oral — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Talphera, Inc — full company profile →
Who can join
Adults 18 to 45, any sex, with Pharmacokinetics. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
AUC (0 - Inf)
Time frame: 24 hours
total amount of sufentanil absorbed -
Cmax
Time frame: 24 hours
maximum plasma concentration -
Tmax
Time frame: 24 hours
time to maximum plasma concentration -
CST 1/2
Time frame: 24 hours
time for maximum plasma concentration to decrease by 50%
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01639729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Talphera, Inc trials
Trials by the same sponsor.
- NCT02662764 — Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01639729 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Talphera, Inc
- Last refreshed: 16 September 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01639729.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing