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Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Javelin Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00520104
First received: August 21, 2007
Last updated: February 27, 2008
Last verified: August 2007
History of Changes
  Purpose

This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.


Condition Intervention Phase
Pharmacokinetics
 Drug: intranasal ketamine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: multiple ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2007
Estimated Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
intranasal ketamine
 Drug: intranasal ketamine
drug interaction
Experimental: B
oxymetazoline plus intranasal ketamine
 Drug: intranasal ketamine
drug interaction
Experimental: C
intranasal steroid plus intranasal ketamine
 Drug: intranasal ketamine
drug interaction

Detailed Description:

To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults
  • Patients with Allergic Rhinitis

Exclusion Criteria:

  • Under age 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520104

Locations
United States, Massachusetts
Javelin Pharmaceuticals
Cambridge, Massachusetts, United States, 02140
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

No publications provided

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00520104     History of Changes
Other Study ID Numbers: KET-PK-008
Study First Received: August 21, 2007
Last Updated: February 27, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013