Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00520169

Enrollment

Registered

2007-08-23

Start date

2007-07-31

Completion date

2007-09-30

Last updated

2008-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

bioavailability

Brief summary

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.

Detailed description

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

Interventions

DRUGintranasal ketamine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults

Exclusion criteria

* under 18 years

Design outcomes

Primary

Measure	Time frame
ketamine pharmacokinetics	multiple

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026