Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

Javelin Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: intranasal ketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520104

KET-PK-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults
• Patients with Allergic Rhinitis

Exclusion criteria

• Under age 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

A

Experimental group

Description:

intranasal ketamine

Treatment:

Drug: intranasal ketamine

B

Experimental group

Description:

oxymetazoline plus intranasal ketamine

Treatment:

Drug: intranasal ketamine

C

Experimental group

Description:

intranasal steroid plus intranasal ketamine

Treatment:

Drug: intranasal ketamine