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OpenTrials
Completed

NCT Number: NCT02082236

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 SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment Arm A: Sufenta®

Drug

Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute

Treatment B: Sufentanil SSM 30 mcg

Drug

single-dose SSM 30 mcg

Treatment C: SSM 15 mcg

Drug

2 consecutive doses of SSM 15 mcg administered 20 minutes apart

Treatment D: SSM 30 mcg

Drug

12 consecutive doses of SSM 30 mcg administered 1 hour apart

Primary outcomes

  1. Area Under the Curve

    Time frame: 9 days, not including a 30 day screening window

    Area under the plasma concentration time curve

Other outcomes

  1. C max

    Time frame: 9 days

    Maximum plasma concentration

  2. T max

    Time frame: 9 days

    Time to reach maximum plasma concentration

  3. Context Sensitive Half-Time (CST½)

    Time frame: 9 hours

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2014
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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