Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00520104

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 I

Drug Information available for: Ketamine Ketamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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

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
A: Experimental intranasal ketamine	Drug: intranasal ketamine drug interaction
B: Experimental oxymetazoline plus intranasal ketamine	Drug: intranasal ketamine drug interaction
C: Experimental 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

More Information

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

Study placed in the following topic categories:

Excitatory Amino Acids
Ketamine

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative

Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009