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

Javelin Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662883

KET-PK-009

Details and patient eligibility

About

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

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adults
• nonsmoker
• no drug use

Exclusion criteria

• nasal abnormalities
• airway abnormalities

Trial design

18 participants in 1 patient group

A

Experimental group

Description:

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

Treatment:

Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate