A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
Condition: Healthy Adult Participants
Intervention: Vortioxetine
Intervention description: Vortioxetine tablet
Intervention MeSH terms: Vortioxetine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the bioequivalence of a single oral administration
      of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg
      tablets in Japanese healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be a healthy Japanese adult volunteer.

          2. Understand the contents of the study and is capable of providing written consent to
             participate in the study.

          3. Be willing to comply with all study procedures and restrictions.

          4. Aged between ≥20 and ≤45 years at the time of screening.

          5. Have a BMI of ≥18.5 and ≤24.9 (kg/m^2) and a body weight of ≥50 kg at the time of
             screening.

          6. Be a extensive metabolizer (EM) based on CYP2D6 genotyping at the time of screening.

          7. A female participant of childbearing potential with a non-sterilized male partner must
             agree to routinely use appropriate contraception during the study from the time of
             signing informed consent until 4 weeks after last dosing of the study drug.

        Exclusion Criteria:

          1. Has received any investigational drug within 90 days before screening for this study.

          2. Previously received Lu AA21004 before participation in this study.

          3. Is an employee of the sponsor or the study site, or immediate family member, or is in
             a dependent relationship with a study site employee who is involved in the conduct of
             this study (eg, spouse, parent, child, sibling) or who may be coerced to provide
             consent.

          4. Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic,
             renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which
             may affect study participation or study results.

          5. Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy)
             or has had an anaphylactic reaction or significant intolerance to prescription drugs,
             over the counter (OTC) drugs, or foods.

          6. Has a positive pregnancy test at the time of screening or Day -1.

          7. Is a pregnant or lactating female.

          8. Has a positive urine drug screen test at the time of screening or Day -1.

          9. Has a history of drug abuse (defined as any illicit drug use) or has a history of
             alcohol dependence within 2 years before the start of screening or is unwilling to
             agree to abstain from alcohol and drugs throughout the study.

         10. Consumes 6 or more servings of caffeinated beverages (containing about 120 mg of
             caffeine per serving) such as of coffee, tea, cola, or energy drinks.

         11. Is a smoker who smoked cigarettes or used nicotine-containing products (such as
             nicotine patch) within 6 months before the Period 1 study drug administration.

         12. Used any of the excluded drugs, dietary products or foods during the specified time
             periods, or will need any of them during the study period.

         13. Has any current or recent gastrointestinal diseases that would be expected to
             influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux,
             peptic ulcer disease, erosive esophagitis, frequent [more than once per week]
             occurrence of heartburn), or any surgical intervention (Stomach, cholecystectomy
             etc.).

         14. Has a history of cancer.

         15. Has a positive test result for any of the following at the time of screening:
             hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human
             immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.

         16. Has poor peripheral venous access.

         17. Has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at
             least 400 mL within 12 weeks (84 days) prior to the start of Period 1 study drug
             administration.

         18. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364
             days) prior to the start of Period 1 study drug administration.

         19. Has undergone blood component collection within 2 weeks (14 days) prior to the start
             of Period 1 study drug administration.

         20. Has any clinically relevant abnormality in vital signs or 12-lead electrocardiograms
             (ECG) at screening or on Day -1 of Period 1.

         21. Has abnormal laboratory test values at screening or on Day -1 of Period 1 indicating
             clinically relevant underlying disease, or showing alanine aminotransferase (ALT)
             and/or aspartate aminotransferase (AST) >1.5×upper limit of normal (ULN).

         22. Is unlikely to comply with the protocol requirements or is unsuitable as a participant
             of this study for any other reason in the opinion of the investigator or
             sub-investigator.