Effect of Delivery Route on PK of Sufentanil NanoTab

Talphera

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment A: Sufentanil IV; Drug: Treatment D: Sufentanil NanoTab Oral; Drug: Treatment C: Sufentanil NanoTab Buccal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639729

IAP102

Details and patient eligibility

About

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• body mass index 18 - 30

Exclusion criteria

• pregnant females
• smokers
• pulmonary disease
• sleep apnea

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 6 patient groups

Sequence 1 - Treatment A, B, C, D

Experimental group

Description:

15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual

Sequence 2 - Treatment A, B, D, C

Experimental group

Description:

15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual

Sequence 3 - Treatment A, C, B, D

Experimental group

Description:

15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual

Sequence 4 - Treatment A, C, D, B

Experimental group

Description:

15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual

Sequence 5 - Treatment A, D, B, C

Experimental group

Description:

15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual

Sequence 6 - Treatment A, D, C, B

Experimental group

Description:

15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual

Treatment:

Drug: Treatment D: Sufentanil NanoTab Oral

Drug: Treatment C: Sufentanil NanoTab Buccal

Drug: Treatment A: Sufentanil IV

Drug: Treatment B: Sufentanil NanoTab Sublingual