Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

Javelin Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: intranasal ketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520169

KET-PK-007

Details and patient eligibility

About

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.

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults

Exclusion criteria

• under 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 3 patient groups

A

Active Comparator group

Description:

oral ketamine

Treatment:

Drug: intranasal ketamine

B

Experimental group

Description:

intranasal ketamine

Treatment:

Drug: intranasal ketamine

C

Active Comparator group

Description:

intravenous ketamine

Treatment:

Drug: intranasal ketamine