A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
Condition: Japanese Healthy Adult Male Participants
Intervention: TAK-536; TAK-536
Intervention description: TAK-536 granules.; TAK-536 tablet.
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: 14.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the bio-equivalence of a single oral administration
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial
      formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period,
      2-treatment, cross-over design.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or sub-investigator, the participant is capable of
             understanding and complying with protocol requirements.

          2. Signs and dates a written, informed consent form prior to the initiation of any study
             procedures.

          3. Is a Japanese healthy adult male.

          4. Aged 20 to 35 years, inclusive, at the time of informed consent.

          5. Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and
             25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.

        Exclusion Criteria:

          1. Has suspected hypotension with associated physical findings, such as dizziness
             postural, facial pallor, or cold sweats based on evaluation/physical examination at
             Screening, on the day before the study drug administration (Day -1) in Period 1, or up
             to the study drug administration on the Period 1.

          2. Has received any study drug within 16 weeks (112 days) prior to the study drug
             administration in Period 1.

          3. Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic
             agent.

          4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results.

          5. Has a known hypersensitivity to any component of the formulation of TAK-536 or any
             angiotensin II receptor blocker (ARB).

          6. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use)
             at Screening.

          7. 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 visit or is unwilling to agree to abstain
             from alcohol and drugs throughout the study.

          8. Has taken any excluded medication, supplements, dietary products, or food products
             during the time periods specified in the protocol.

          9. Has any current or recent (within 6 months) gastrointestinal diseases that would be
             expected to influence the absorption of drugs (that is, a history of malabsorption,
             esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once
             per week] occurrence of heartburn, or any surgical intervention).

         10. Has a history of cancer, except basal cell carcinoma which has been in remission for
             at least 5 years prior to Day 1 of Period 1.

         11. 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. Has poor peripheral venous access.

         13. Has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks
             (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study
             drug administration in Period 1.

         14. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364
             days) prior to the start of the study drug administration in Period 1.

         15. Has undergone blood component collection within 2 weeks (14 days) prior to the start
             of the study drug administration in Period 1.

         16. Has an abnormal (clinically significant) ECG at Screening or prior to the study drug
             administration in Period 1.

         17. Has abnormal laboratory values that suggest a clinically significant underlying
             disease, or participant with the following laboratory abnormalities at Screening or
             prior to the study drug administration in Period 1: alanine aminotransferase (ALT)
             and/or aspartate aminotransferase (AST) greater than (>) 1.5 * the upper limits of
             normal (ULN).

         18. Who, in the opinion of the investigator or sub-investigator, is unlikely to comply
             with the protocol or is unsuitable for any other reason.