ADASUVE-Lorazepam Drug-Drug Interaction

Phase 4 Completed 22 enrolled Alexza Pharmaceuticals, Inc.

RandomizedCrossoverQuadruple-blindOther

Summary

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Timeline

Start: 2013-06
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

paper There was no difference between inhaled loxapine + IM lorazepam and either agent alone on respiration or pulse oximetery PMID 27022468 ↗

Publications

Results Spyker DA, Cassella JV, Stoltz RR, Yeung PP. Inhaled loxapine and intramuscular lorazepam in healthy volunteers: a randomized placebo-controlled drug-drug interaction study. Pharmacol Res Perspect. 2015 Dec 17;3(6):e00194. doi: 10.1002/prp2.194. eCollection 2015 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorazepam	Small molecule	1 mg	Intramuscular
Subject	loxapine	Small molecule	10 mg	Inhaled

Indications

No indication recorded.