A Multiple-Dose, Randomized, Double-Blind, Placebo- and Active-Controlled, Four-Arm, Parallel Group Thorough QT/QTc Study to Evaluate the Electrophysiologic Effects of Sativex.

Inclusion criteria

• Healthy male and female subjects 18 to 45 years of age.
• Body Mass Index (BMI) within the range of 19 to 29.9 kg/m2, and a minimum weight of at least 50 kg at screening.
• Non-users of tobacco products (minimum of 6 months)
• Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, ECG, and laboratory evaluation at screening and admission to the treatment session, as judged by the investigator or designee.
• Systolic blood pressure between 90 to 140 mmHg and diastolic blood pressure between 50 and 90 mmHg at screening and admission to the treatment session.
• Subjects with reproductive potential required to practice abstinence or be using and willing to continue using a medically acceptable form of birth control for at least one month prior to screening (at least 3 months for oral contraceptives) and for at least 60 days after the last study drug administration.
• Female subjects required to have a negative serum pregnancy test at screening and admission to the treatment session.
• Subjects must have been able to speak, read and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
• Subjects must have understood and provided written informed consent prior to initiation of any protocol-specific procedures.
• Subjects must have been willing and able to abide by all study requirements and restrictions.