Healthy
Conditions
Keywords
Plasma concentrations
Brief 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.
Interventions
DRUGTreatment Arm A: Sufenta®
Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
DRUGTreatment B: Sufentanil SSM 30 mcg
single-dose SSM 30 mcg
DRUGTreatment C: SSM 15 mcg
2 consecutive doses of SSM 15 mcg administered 20 minutes apart
DRUGTreatment D: SSM 30 mcg
12 consecutive doses of SSM 30 mcg administered 1 hour apart
Sponsors
Talphera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Non-smoking male or female subjects 2. Aged between 18 and 45 years inclusive 3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
Exclusion criteria
1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications 2. Female subjects who are pregnant 3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve | 9 days, not including a 30 day screening window | Area under the plasma concentration time curve |
Other
| Measure | Time frame | Description |
|---|---|---|
| C max | 9 days | Maximum plasma concentration |
| T max | 9 days | Time to reach maximum plasma concentration |
| Context Sensitive Half-Time (CST½) | 9 hours | — |
Countries
United States
Outcome results
None listed