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
Location
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
* 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