Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Talphera

Status and phase: Completed; Phase 1

Conditions: Plasma Concentrations

Treatments: Drug: Single dose of SUF NT 15 mcg; Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Study type: Interventional

Funder types: Industry

Identifiers

NCT01761565

IAP101

Details and patient eligibility

About

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non smoking
• Ages 18 to 45 year, inclusive
• BMI between 18 and 30

Exclusion criteria

• Subjects taking any prescription or OTC medications or vitamins or supplements
• Pregnant females
• Subjects with pulmonary disease or sleep apnea

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

Experimental group

Description:

Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Treatment:

Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Drug: Single dose of SUF NT 15 mcg