Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

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.

Intervention / Treatment

  • Intranasal ketamine (DRUG)
    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.

Condition or Disease

  • Healthy

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 32 (ACTUAL)
Funded by: Industry
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Jul 01, 2007
Primary Completion: Sep 01, 2007 ACTUAL
Completion Date: Sep 01, 2007 ACTUAL
Study First Posted: Aug 23, 2007 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Jan 09, 2008

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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

Eligibility Criteria

Sex: All
Minimum Age: 18
Healthy Volunteers: Yes

Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* under 18 years

Primary Outcomes
  • ketamine pharmacokinetics multiple

More Details

NCT Number: NCT00520169
Other IDs: KET-PK-007
Study URL: https://clinicaltrials.gov/study/NCT00520169
Last updated: Sep 29, 2023