Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex

Phase 1 Completed 36 enrolled Jazz Pharmaceuticals

RandomizedCrossoverOpen-labelBasic science

Summary

Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when given in combination with these other drugs.

Timeline

Start: 2008-02
Primary completion: 2008-03
Completion: 2008-03

Publications

Results Stott C, White L, Wright S, Wilbraham D, Guy G. A Phase I, open-label, randomized, crossover study in three parallel groups to evaluate the effect of Rifampicin, Ketoconazole, and Omeprazole on the pharmacokinetics of THC/CBD oromucosal spray in healthy volunteers. Springerplus. 2013 May 24;2(1):236. doi: 10.1186/2193-1801-2-236. Print 2013 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	—
Subject	Nabiximols	Other / unclassified	—	Other
Subject	Omeprazole	Other / unclassified	40 mg	—
Subject	Rifampin	Small molecule	600 mg	—

Indications

No indication recorded.