Clinical trials: Sufentanil
Major Upper or Lower Abdominal Surgery
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery.
- Trial name
- NCT00718081
- Testing
- Oral sufentanil
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Pharmacokinetics
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.
- Trial name
- NCT01721070
- Testing
- Sufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Plasma Concentrations
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
- Trial name
- NCT01761565
- Testing
- Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Pharmacokinetics
Effect of Delivery Route on PK of Sufentanil NanoTab
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.
- Trial name
- NCT01639729
- Testing
- Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Healthy
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…
- Trial name
- NCT02082236
- Testing
- Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg, Treatment C: SSM 15 mcg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc