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Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

NCT ID: NCT00520169

Last Updated: 2008-01-10

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

oral ketamine

Group Type ACTIVE_COMPARATOR

intranasal ketamine

Intervention Type DRUG

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.

B

intranasal ketamine

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

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.

C

intravenous ketamine

Group Type ACTIVE_COMPARATOR

intranasal ketamine

Intervention Type DRUG

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.

Interventions

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intranasal 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults

Exclusion Criteria

* under 18 years
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-007

Identifier Type: -

Identifier Source: org_study_id

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