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CompletedNCT00520169Updated Jan 10, 2008

Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

A Phase 1 interventional study of intranasal ketamine in Healthy, sponsored by Javelin Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-10.

Sponsored by Javelin Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Read the detailed description

To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

02

Conditions studied

  • Healthy

Keywords

  • bioavailability
03

In context

Lead sponsor

Javelin Pharmaceuticals is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults

Exclusion criteria

Exclusion Criteria:

  • under 18 years
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    A

    oral ketamine

    Drug: intranasal ketamine

  • Experimental
    B

    intranasal ketamine

    Drug: intranasal ketamine

  • Active comparator
    C

    intravenous ketamine

    Drug: intranasal ketamine

Interventions

  • Drugintranasal ketamine

    A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.

06

What researchers measure

Primary outcomes

  1. ketamine pharmacokinetics

    Time frame: multiple

07

Study locations

1 site
  • Javelin Pharmaceuticals
    Cambridge, Massachusetts 02140, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520169
Lead sponsor
Javelin Pharmaceuticals
First posted
Aug 23, 2007
Start date
Jul 2007
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Jan 10, 2008

Study contacts

Javelin Pharmaceuticals
study director · Javelin Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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