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Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

Information source: Javelin Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PMI-150 (intranasal ketamine HCl); mometasone furoate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Javelin Pharmaceuticals

Official(s) and/or principal investigator(s):
Javelin Pharmaceuticals, Inc, Study Director, Affiliation: Javelin Pharmaceuticals

Summary

To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Clinical Details

Official title: A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Pharmacokinetic parameters

Detailed description: 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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy adults

- nonsmoker

- no drug use

Exclusion Criteria:

- nasal abnormalities

- airway abnormalities

Locations and Contacts

Baltimore, Maryland 21225, United States
Additional Information

Starting date: November 2007
Last updated: April 21, 2008

Page last updated: August 23, 2015

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