Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
Brief Summary
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
Intervention / Treatment
-
PMI-150 (intranasal ketamine HCl); mometasone furoate (DRUG)* 1 dose PMI-150 (intranasal ketamine HCl); day 1 * mometasone furoate, daily; days 2-15 * 1 dose PMI-150 (intranasal ketamine HCl); day 15
Condition or Disease
- Healthy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 18 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | N/A |
Masking |
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Clinical Trial Dates
| Start date: | Nov 01, 2007 | |
|---|---|---|
| Primary Completion: | Feb 01, 2008 | ACTUAL |
| Completion Date: | Feb 01, 2008 | ACTUAL |
| Study First Posted: | Apr 21, 2008 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Apr 21, 2008 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* healthy adults
* nonsmoker
* no drug use
Exclusion Criteria:
* nasal abnormalities
* airway abnormalities
* healthy adults
* nonsmoker
* no drug use
Exclusion Criteria:
* nasal abnormalities
* airway abnormalities
Primary Outcomes
-
Pharmacokinetic parameters 15 days
More Details
| NCT Number: | NCT00662883 |
|---|---|
| Other IDs: | KET-PK-009 |
| Study URL: | https://clinicaltrials.gov/study/NCT00662883 |
Last updated: Sep 29, 2023