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Clinical trial

An Open Label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics and Tolerability of a Single Oromucosal Dose of 4 Sprays of Sativex(Containing 10.8 mg Delta-9-tetrahydrocannabinol [THC] and 10 mg Cannabidiol [CBD]) in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function.

NCT01887301 is registered in ClinicalTrials.gov with Jazz Pharmaceuticals as lead sponsor.

NCT NCT01887301
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics and Tolerability of a Single Oromucosal Dose of 4 Sprays of Sativex(Containing 10.8 mg Delta-9-tetrahydrocannabinol [THC] and 10 mg Cannabidiol [CBD]) in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function.
Lead sponsor
Jazz Pharmaceuticals
Phase
Phase 1
Overall status
Completed
Start date
July 31, 2013
Completion date
May 31, 2014
Enrollment
32 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

hepatic impairment