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Multiple Dose Pharmacokinetics of Intranasal Ketamine

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ClinicalTrials.gov Identifier: NCT00519987
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : January 10, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: intranasal ketamine Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : June 2007
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment A
intranasal ketamine
Drug: intranasal ketamine
intranasal ketamine


Outcome Measures

Primary Outcome Measures :
  1. pharmacokinetics [ Time Frame: multiple ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • under 18 years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519987


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

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00519987     History of Changes
Other Study ID Numbers: KET-PK-002
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: January 2008

Keywords provided by Javelin Pharmaceuticals:
pharmacokinetics

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action