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

Talphera

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment Arm A: Sufenta®; Drug: Treatment C: SSM 15 mcg; Drug: Treatment B: Sufentanil SSM 30 mcg; Drug: Treatment D: SSM 30 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02082236

SAP101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Treatment A

Active Comparator group

Description:

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

Treatment:

Drug: Treatment Arm A: Sufenta®

Treatment B

Experimental group

Description:

Single dose of SSM 30 mcg

Treatment:

Drug: Treatment B: Sufentanil SSM 30 mcg

Treatment C

Experimental group

Description:

2 consecutive doses of SSM 15 mcg administered 20 minute apart

Treatment:

Drug: Treatment C: SSM 15 mcg

Treatment D

Experimental group

Description:

12 consecutive doses of SSM 30 mcg administered 1 hour apart

Treatment:

Drug: Treatment D: SSM 30 mcg