This trial is active, not recruiting.

Condition pharmacokinetics
Treatment intranasal ketamine
Phase phase 1
Sponsor Javelin Pharmaceuticals
Start date August 2007
End date February 2008
Trial size 48 participants
Trial identifier NCT00520104, KET-PK-008


This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
intranasal ketamine
intranasal ketamine
drug interaction
oxymetazoline plus intranasal ketamine
intranasal ketamine
drug interaction
intranasal steroid plus intranasal ketamine
intranasal ketamine
drug interaction

Primary Outcomes

time frame: multiple

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Healthy adults - Patients with Allergic Rhinitis Exclusion Criteria: - Under age 18

Additional Information

Official title A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Description To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Javelin Pharmaceuticals.