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Multiple Dose Pharmacokinetics of Intranasal Ketamine

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: August 21, 2007
Last updated: January 9, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Healthy Drug: intranasal ketamine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label, Single Center Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Administrations of 30 mg PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: multiple ]

Enrollment: 18
Study Start Date: June 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
intranasal ketamine
Drug: intranasal ketamine
intranasal ketamine

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • under 18 years
  Contacts and Locations
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Please refer to this study by its identifier: NCT00519987

Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00519987     History of Changes
Other Study ID Numbers: KET-PK-002
Study First Received: August 21, 2007
Last Updated: January 9, 2008

Keywords provided by Javelin Pharmaceuticals:

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017