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Multiple Dose Pharmacokinetics of Intranasal Ketamine

NCT ID: NCT00519987

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-08-31

Brief Summary

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This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

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Detailed Description

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To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Treatment A

intranasal ketamine

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

intranasal ketamine

Interventions

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intranasal ketamine

intranasal ketamine

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

Other Identifiers

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KET-PK-002

Identifier Type: -

Identifier Source: org_study_id

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