Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

Phase 1CompletedNCT00520169

Javelin Pharmaceuticals32 enrolled

Overview

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

intranasal ketamineDRUG

A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults Exclusion Criteria: * under 18 years

Locations (1)

Javelin Pharmaceuticals

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

ketamine pharmacokinetics

Time frame: multiple

Data from ClinicalTrials.gov

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