CClinicalTrials.gg
Status unknownNCT00520104Updated Feb 29, 2008

Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

A Phase 1 interventional study of intranasal ketamine in Pharmacokinetics, sponsored by Javelin Pharmaceuticals. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-02-29.

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

The sponsor has not verified this record recently (last verified Aug 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Read the detailed description

To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.

02

Conditions studied

  • Pharmacokinetics
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
  • Patients with Allergic Rhinitis

Exclusion criteria

Exclusion Criteria:

  • Under age 18
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    A

    intranasal ketamine

    Drug: intranasal ketamine

  • Experimental
    B

    oxymetazoline plus intranasal ketamine

    Drug: intranasal ketamine

  • Experimental
    C

    intranasal steroid plus intranasal ketamine

    Drug: intranasal ketamine

Interventions

  • Drugintranasal ketamine

    drug interaction

06

What researchers measure

Primary outcomes

  1. 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 Feb 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520104
Lead sponsor
Javelin Pharmaceuticals
First posted
Aug 23, 2007
Start date
Aug 2007
Primary completion
Feb 2008
Completion
Mar 2008 (estimated)
Last update
Feb 29, 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 status unknown, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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