A Bioequivalence Study of TAK-536 Pediatric Formulation
Condition: Japanese Healthy Adult Males
Intervention: TAK-536 Tablet; TAK-536 Dry Syrup Formulation; TAK-536 Ganule Formulation
Intervention description: TAK-536 10 mg tablet; TAK-536 dry syrup formulation; TAK-536 granule formulation
Intervention MeSH terms: Azilsartan medoxomil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2
      different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536
      commercial tablet in healthy Japanese adult male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or the sub-investigator, the participant is capable
             of understanding and complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form (ICF) and any
             required privacy authorization prior to the initiation of any study procedures.

          3. The participant is a healthy Japanese adult male volunteer.

          4. The participant is between 20 and 35 years of age at the time of informed consent.

          5. The participant has a body weight of at least 50.0 kilogram (kg) and has a body mass
             index (BMI) between 18.5 and 25.0 kilogram per meter square (kg/m^2) at the time of
             screening.

        Exclusion Criteria:

          1. The participant has shown symptoms of dizziness on standing up, facial pallor, cold
             sweat, etc, and suspected hypotension at medical examination/physical findings at
             screening and the day before administration of the study drug for Period 1, and before
             administration of the study drug for Period 1.

          2. The participant has received any investigational compound within 16 weeks (112 days)
             prior to the start of study medication for Period 1

          3. The participant has received TAK-536 or TAK-491 in a previous clinical study or as a
             therapeutic agent.

          4. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease
             or other abnormality which may impact the ability of the participant to participate or
             potentially confound the study results.

          5. The participant has a known hypersensitivity to TAK-536 or angiotensin II receptor
             blockers.

          6. The participant has positive results in the urine drug screening test at screening.

          7. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 2 years prior to the screening or is unwilling to
             agree to abstain from alcohol and drugs throughout the study period.

          8. The participant has taken any excluded medication, supplements, or food products
             during the time periods.

          9. The participant has current or recent (within 6 months) gastrointestinal disease 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 (ie,
             cholecystectomy).

         10. The participant has a history of cancer.

         11. The participant has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen,
             or serological reactions for syphilis at screening.

         12. The participant has poor peripheral venous access.

         13. The participant 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 study
             medication administration for Period 1.

         14. The participant has undergone whole blood collection of at least 800 mL in total
             within 52 weeks (364 days) prior to the start of study medication administration for
             Period 1.

         15. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of study medication administration for Period 1.

         16. The participant has an abnormal (clinically significant) electro-cardiogram at
             screening or prior to the start of study medication for Period 1.

         17. The participant has abnormal laboratory values at screening or prior to the start of
             study medication for Period 1 that suggest a clinically significant underlying disease
             or participant with the following lab abnormalities: alanine transaminase (ALT) or
             aspartate transaminase (AST) greater than (>)1.5 times the upper limits of normal.

         18. The participant who, in the opinion of the investigator or the sub-investigator, is
             unlikely to comply with the protocol or is unsuitable for any other reason.