Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00520169

Purpose

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Condition	Intervention	Phase
Healthy	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, Parallel Assignment, Bio-availability Study
Official Title:	A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

ketamine pharmacokinetics [ Time Frame: multiple ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	July 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator oral ketamine	Drug: intranasal ketamine A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
B: Experimental intranasal ketamine	Drug: intranasal ketamine A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
C: Active Comparator intravenous ketamine	Drug: intranasal ketamine A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.

Detailed Description:

To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

under 18 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520169

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-007
Study First Received:	August 21, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00520169
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

bioavailability

Study placed in the following topic categories:

Excitatory Amino Acids
Ketamine
Healthy

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