Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02082236

Run by

Talphera, Inc

People needed

40

Starts

2014-05-01

Expected to finish

2014-05-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• PRA — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.