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Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

NCT ID: NCT00520104

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

intranasal ketamine

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

drug interaction

B

oxymetazoline plus intranasal ketamine

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

drug interaction

C

intranasal steroid plus intranasal ketamine

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

drug interaction

Interventions

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intranasal ketamine

drug interaction

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults
* Patients with Allergic Rhinitis

Exclusion Criteria

* Under age 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Javelin Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Javelin Pharmaceuticals

Principal Investigators

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Javelin Pharmaceuticals

Role: STUDY_DIRECTOR

Javelin Pharmaceuticals

Locations

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Javelin Pharmaceuticals

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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KET-PK-008

Identifier Type: -

Identifier Source: org_study_id