A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
Condition: Healthy Volunteers
Intervention: Alogliptin; Pioglitazone; SYR-322-4833 BL
Intervention description: Alogliptin tablets.; Pioglitazone tablets.; SYR-322-4833 BL FDC tablets.
Intervention MeSH terms: Pioglitazone; Alogliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the relative bioavailability and bioequivalence of 2
      strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and
      pioglitazone tablets in healthy Russian participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy male or female.

          2. Has an estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90
             milliliter per minute (mL/min).

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30.0
             kilogram per square meter (kg/m^2), inclusive at Screening.

        Exclusion Criteria:

          1. Has participated in a clinical study within 3 months prior to Check-in (Day-1).

          2. Has a fasting blood glucose level lower than 3.88 millimole per liter (mmol/L).

          3. Has received alogliptin or pioglitazone in a previous clinical study or as a
             therapeutic agent within 90 days prior to Check-in (Day-1).

          4. Experienced acute infectious diseases within 4 weeks prior to Screening.

          5. Has a positive urine drug result for super potent substances and drugs of abuse
             (defined as any illicit drug use) or positive alcohol breath test at Screening or
             Check-in (Day -1).

          6. Consumes over 10 drinks weekly (1 drink is equivalent to 0.5 liters of beer, 200
             milliliter (mL) of dry wine or 50 mL of ardent spirits) or has a history of
             alcoholism, drug and/or substance abuse.

          7. Has a non-standard diet (example, vegetarian or vegan) or lifestyle (including night
             time work, extreme physical activity such as weights lifting), which may interfere
             with the trial.

          8. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to
             Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).

          9. Has poor peripheral venous access.

         10. Has donated or lost 450 mL or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day
             1 of Period 1.

         11. Has consumed caffeine or xanthine-containing food or drinks within 72 hours prior to
             Check-in (Day -1).

         12. Has dehydration due to vomiting, diarrhea, or any other reason within 24 hours prior
             to study start.

         13. Has drug intolerance.