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NCT01721070 · ClinicalTrials.gov registry record · Phase 1

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

A Phase 1 study, sponsored by Talphera.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01721070: Completed Phase 1 study, sponsored by Talphera.

NCT01721070 is a Phase 1 study that has completed, run by Talphera. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01721070, a Phase 1 study, has completed, sponsored by Talphera.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

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

Primary Outcome

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

Interventions

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

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2012-11
Est. Completion 2012-12
Phase Phase 1
Talphera

18 total trials

What the finished NCT01721070 record still lists

NCT01721070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which Sufentanil NanoTab (SUF NT) 15 mcg is the first listed.

NCT01721070 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01721070 about?

NCT01721070 is a clinical study titled "Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics". Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

What is the current status of trial NCT01721070?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-11. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01721070?

The interventions under investigation include: Sufentanil NanoTab (SUF NT) 15 mcg (DRUG), Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg (DRUG).

Who is sponsoring clinical trial NCT01721070?

This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01721070's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01721070, the US trial registry maintained by the National Library of Medicine. NCT01721070 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.