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OpenTrials
Completed

NCT Number: NCT01639729

Effect of Delivery Route on PK of Sufentanil NanoTab

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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Key information

Conditions

Pharmacokinetics

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

  • body mass index 18 - 30

Exclusion criteria

  • pregnant females
  • smokers
  • pulmonary disease
  • sleep apnea

Treatment and study plan

Treatment A: Sufentanil IV

Drug

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

Treatment B: Sufentanil NanoTab Sublingual

Drug

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccal

Drug

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

Treatment D: Sufentanil NanoTab Oral

Drug

Single Sufentanil NanoTab 15 mcg swallowed (PO)

Primary outcomes

  1. AUC (0 - Inf)

    Time frame: 24 hours

    total amount of sufentanil absorbed

  2. Cmax

    Time frame: 24 hours

    maximum plasma concentration

  3. Tmax

    Time frame: 24 hours

    time to maximum plasma concentration

  4. CST 1/2

    Time frame: 24 hours

    time for maximum plasma concentration to decrease by 50%

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Official study title

Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2012
Registry last updated
Oct 1, 2015

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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