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

Launched by TAKEDA · Apr 16, 2018

Keywords

ClinConnect Summary

The drug being tested in this study are called Incresync (SYR-322-4833 BL), alogliptin, and pioglitazone. This study will assess the bioequivalence, pharmacokinetics (PK), and safety of alogliptin and pioglitazone administered as individual tablets and as the FDC tablet product in healthy volunteers.

The study will enroll approximately 72 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences to receive one of the following treatments:

* Regimen A: SYR-322-4833 BL (25 mg + 15 mg)
* Regimen B: Alogliptin 25 mg + pioglitazo...

Gender

ALL

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.