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Completed

NCT Number: NCT01721070

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Completed

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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

  • 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

Treatment and study plan

Sufentanil NanoTab (SUF NT) 15 mcg

Drug

Period 1: One dose of SUF NT 15 mcg administered sublingually

Other names: SUF NT 15 mcg

Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg

Drug

Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day

Other names: SUF NT 15 mcg

Primary outcomes

  1. AUC (0-inf)

    Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours

    Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.

  2. Cmax

    Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.

    Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Official study title

IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2012
Registry last updated
Nov 4, 2016

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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