Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT02082236
- Lead Sponsor
- Talphera, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Non-smoking male or female subjects
- Aged between 18 and 45 years inclusive
- Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
Exclusion Criteria
- 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
- Female subjects who are pregnant
- Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area Under the Curve 9 days, not including a 30 day screening window Area under the plasma concentration time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA
🇺🇸Lenexa, Kansas, United States