Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone

Exclusion Criteria

• •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, metabolic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
• •A clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
• •History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone, opioids, or any comparable or similar products.
• •Been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
• •Donated blood or plasma within 30 days prior to the first dose of study medication.
• •Participated in another clinical trial within 30 days prior to the first dose of study medication.
• •Used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
• •Used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
• •Has been treated with any known enzyme altering drugs, such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
• •Smoked or used tobacco products within 60 days prior to the first dose of study medication.
• •History of substance abuse or dependence (including alcohol, opioids, or intravenous drug abuse)
• •Is a female with a positive pregnancy test result.
• •A positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• •A positive urine alcohol test at screening or a positive ethanol breath test at check-in for the study period or has consumed alcohol within 48 hours prior to screening or check-in for the study period.
• •Had a positive test for, or has been treated for hepatitis B, hepatitis C, or HIV.