A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
Condition: Healthy
Intervention: SYR-472
Intervention description: SYR-472 25mg, 50mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25
      milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who understand the outline of the clinical study and are capable of
             complying with their responsibilities as participants, as judged by the investigator
             or sub investigator.

          2. Participants who can sign and date the informed consent form before the initiation of
             the study procedure.

          3. Healthy Japanese adult males.

          4. Participants who are 20 to 35 years of age at the time of informed consent.

          5. Participants who weigh 50.0 kilogram (kg) or more with a body mass index (BMI) of 18.5
             to less than 25.0 kilogram per square meter (kg/m^2) in the screening period.

        Exclusion Criteria:

          1. Participants who were administered any investigational product within 16 weeks (112
             days) before the start of the study drug administration in stage 1.

          2. Participants who have received SYR-472 in the past.

          3. Employees of the study site, their family members, those who are in a dependency
             relationship with employees of the study site involved in the conduct of the study
             (for example [e.g.], spouse, parents, children, brothers and sisters), and those who
             might be coerced to consent to participate in the study.

          4. Participants who have poorly controlled, clinically significant abnormalities of the
             nervous system, cardiovascular system, lung, liver, kidneys, metabolism,
             gastrointestinal system, urinary system, or endocrinological system, which possibly
             may affect study participation or study results.

          5. Participants who have a positive urine drug test in the screening period.

          6. Participants who need to use drugs or foods listed in the table of prohibited
             concomitant drugs and foods.

          7. Participants who have a history of hypersensitivity or allergy to drugs (including
             SYR-472 and its ingredients).

          8. Participants who currently have or recently had (within the past 6 months)
             gastrointestinal disease that may affect drug absorption (malabsorption, esophageal
             reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week]
             heartburn, surgical intervention [e.g., cholecystectomy]).

          9. Participants with a past history of cancer.

         10. Participants who are positive for any of the following during the screening period:
             hepatitis B virus surface antigen (HBsAg), antibody against hepatitis C virus (HCV),
             human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological test for
             syphilis.

         11. Participants with difficulty having blood collected from a peripheral vein.

         12. Participants who donated 200 milliliter (mL) or more of whole blood within the 4 weeks
             (28 days) or 400 mL or more of whole blood within the 12 weeks (84 days) before
             starting the study drug administration in stage 1.

         13. Participants who donated a total of 800 mL or more of whole blood within the 52 weeks
             (364 days) before starting the study drug administration in stage 1.

         14. Participants who donated blood components within the 2 weeks (14 days) before starting
             the study drug administration in stage 1.

         15. Participants who show clinically significant abnormalities in electrocardiogram (ECG)
             during the screening period or on Day 1 (before the study drug administration).

         16. Participants who have laboratory test abnormalities suggestive of a clinically
             significant primary disease or who have abnormal values in any of the following
             parameters: alanine aminotransferase (ALT) or aspartate serum transaminase AST
             exceeding 1.5 times the upper limit of the normal range.

         17. Participants who are unlikely to comply with the study protocol or are ineligible for
             the study for any other reason, as judged by the investigator or sub investigator.