Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Exclusion Criteria

• •Evidence of a clinically significant disease or abnormalities, including an active, current infection or clinically significant infection within 8 weeks prior to the first dose
• •Severe allergic reaction, angioedema, or anaphylaxis to drugs, or food or latex allergies
• •Subject has an estimated creatinine clearance of ≤ 70 mL
• •Subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations
• •Subject has significant ECG abnormality, history or presence of cardiac arrhythmia or conduction abnormalities, or bradycardia (\< 45 bpm)
• •Subject has a history of vasovagal syncope, or symptomatic orthostatic hypotension
• •Subject has as a history of or current alcohol abuse and/or other drug addiction
• •Subject has received an investigational drug (including investigational vaccines) within 5 half-lives of such drug prior to Study Day 1
• •Subject has received CYP2D inhibitors (e.g., fluoxetine, sertraline, duloxetine, bupropion, chloroquine, cimetidine, diphenhydramine) less than 3 weeks prior to administration of the initial dose of study drug
• •Subject has suicidal thinking and behavior (suicidality) or other significant psychiatric disorders based on self-disclosure during interview (Screening visit)
• •Subject has a history of acute narrow-angle glaucoma
• •Subject has as any condition that would make him or her, in the opinion of the Investigator or Sponsor, unsuitable for the study