Determination of Drug Interactions of Certain Nasal Medic... | NCT00520104

Studies
Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

NCT00520104

Sponsor

Javelin Pharmaceuticals

Status

Unknown status

Last Update Posted

Feb 29, 2008Estimated

Enrollment

48Estimated

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

intranasal ketamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Mar 2008Estimated

First Submitted Date

Aug 21, 2007

First Submission Date that Met QC Criteria

Aug 21, 2007

First Posted Date

Aug 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2008

Last Update Posted Date

Feb 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	intranasal ketamine	Drug: intranasal ketamine
B	Experimental	oxymetazoline plus intranasal ketamine	Drug: intranasal ketamine
C	Experimental	intranasal steroid plus intranasal ketamine	Drug: intranasal ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intranasal ketamine	Drug	drug interaction	A B C

Measure	Description	Time Frame
Pharmacokinetics		multiple

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults
Patients with Allergic Rhinitis

Exclusion Criteria:

Under age 18

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javelin Pharmaceuticals	Javelin Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Javelin Pharmaceuticals		Cambridge	Massachusetts	02140	United States