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Effect of Delivery Route on PK of Sufentanil NanoTab

NCT ID: NCT01639729

Last Updated: 2015-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1 - Treatment A, B, C, D

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Sequence 2 - Treatment A, B, D, C

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Sequence 3 - Treatment A, C, B, D

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Sequence 4 - Treatment A, C, D, B

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Sequence 5 - Treatment A, D, B, C

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Sequence 6 - Treatment A, D, C, B

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

Group Type EXPERIMENTAL

Treatment A: Sufentanil IV

Intervention Type DRUG

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingual

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Intervention Type DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oral

Intervention Type DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Interventions

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Treatment A: Sufentanil IV

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Intervention Type DRUG

Treatment B: Sufentanil NanoTab Sublingual

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Intervention Type DRUG

Treatment C: Sufentanil NanoTab Buccal

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Intervention Type DRUG

Treatment D: Sufentanil NanoTab Oral

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* body mass index 18 - 30

Exclusion Criteria

* pregnant females
* smokers
* pulmonary disease
* sleep apnea
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Talphera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Palmer, M.D.

Role: STUDY_DIRECTOR

Talphera, Inc

Locations

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PRA

Lenexa, Kansas, United States

Site Status

Countries

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United States

References

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Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.

Reference Type BACKGROUND
PMID: 25544247 (View on PubMed)

Other Identifiers

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IAP102

Identifier Type: -

Identifier Source: org_study_id

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