Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

Javelin Pharmaceuticals18 enrolled

Overview

To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PMI-150 (intranasal ketamine HCl); mometasone furoateDRUG

* 1 dose PMI-150 (intranasal ketamine HCl); day 1 * mometasone furoate, daily; days 2-15 * 1 dose PMI-150 (intranasal ketamine HCl); day 15

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy adults * nonsmoker * no drug use Exclusion Criteria: * nasal abnormalities * airway abnormalities

Locations (1)

Unnamed facility

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters

Time frame: 15 days

Data from ClinicalTrials.gov

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