Inclusion Criteria:  Healthy male and female subjects; Between 18 and 55 years of age; Provide a signed EC-approved consent form; Generally healthy, in the opinion of the Investigator; Body Mass Index (BMI) 18 to 32 kg/m^2; Using method of contraception; Willing and able to comply with protocol requirements for the duration of the study  Exclusion Criteria:  Subjects taking prohibited medications; Subjects with a history or presence of clinically significant medical or psychiatric disease; Subjects with a history of recreational or opiate use; Subjects with a history of alcohol abuse or moderate to severe substance abuse; Subjects who have regularly used nicotine-containing products; Subjects with a hospital admission or major illness within 1 month prior to Screening; Subjects with a major surgery within 3 months prior to Screening; Subjects who are pregnant or breastfeeding Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 30 days prior to Screening; Subjects who belong to a vulnerable population.