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Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

NCT ID: NCT00662883

Last Updated: 2008-04-22

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Detailed Description

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Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Conditions

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Healthy

Keywords

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ketamine corticosteroid intranasal phase I Healthy volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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A

* PMI-150 (intranasal ketamine HCl), day 1
* mometasone furoate, days 2-15
* PMI-150 (intranasal ketamine HCl), day 15

Group Type EXPERIMENTAL

PMI-150 (intranasal ketamine HCl); mometasone furoate

Intervention Type DRUG

* 1 dose PMI-150 (intranasal ketamine HCl); day 1
* mometasone furoate, daily; days 2-15
* 1 dose PMI-150 (intranasal ketamine HCl); day 15

Interventions

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PMI-150 (intranasal ketamine HCl); mometasone furoate

* 1 dose PMI-150 (intranasal ketamine HCl); day 1
* mometasone furoate, daily; days 2-15
* 1 dose PMI-150 (intranasal ketamine HCl); day 15

Intervention Type DRUG

Other Intervention Names

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Nasonex

Eligibility Criteria

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Inclusion Criteria

* healthy adults
* nonsmoker
* no drug use

Exclusion Criteria

* nasal abnormalities
* airway abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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, Inc.

Principal Investigators

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Javelin Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Javelin Pharmaceuticals

Locations

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Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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KET-PK-009

Identifier Type: -

Identifier Source: org_study_id