Multiple Dose Pharmacokinetics of Intranasal Ketamine

An Open Label, Single Center Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Administrations of 30 mg PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00519987

Enrollment

Registered

2007-08-23

Start date

2007-06-30

Completion date

2007-08-31

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

pharmacokinetics

Brief summary

This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed description

To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Interventions

DRUGintranasal ketamine

intranasal ketamine

Study design

Allocation

Intervention model

SINGLE_GROUP

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
pharmacokinetics	multiple

Outcome results

None listed

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