drugset / Trial / NCT01887301

Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients

NCT01887301

Phase 1 Completed 32 enrolled Jazz Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) in healthy patients and those with hepatic (liver) function impairment.

Timeline

Start
2013-07
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nabiximols Other / unclassified 10 mg Other
Subject Nabiximols Other / unclassified 10.8 mg Other

Indications

No indication recorded.