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NCT00520104 Clinical Trial

Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00520104
Other study ID # KET-PK-008
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received August 21, 2007
Last updated February 27, 2008
Start date August 2007
Est. completion date March 2008

Study information
Verified date August 2007
Source Javelin Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 48
Est. completion date March 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy adults

- Patients with Allergic Rhinitis

Exclusion Criteria:

- Under age 18

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• intranasal ketamine
drug interaction

Locations
Country Name City State
United States Javelin Pharmaceuticals Cambridge Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Javelin Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics multiple No
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