Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Groups 1 and 2 (mild and moderate hepatic impairment)
Group 3 (severe hepatic impairment)
Group 4 (healthy controls)
Exclusion criteria
Groups 1, 2, and 3 (hepatic impairment)
Group 4 (healthy controls)
Primary purpose
Allocation
Interventional model
Masking
32 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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