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.
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 + pioglitazone 15 mg * Regimen C: SYR-322-4833 BL (25 mg + 30 mg) * Regimen D: Alogliptin 25 mg + pioglitazone 30 mg All participants will be asked to take single dose of study medication on Day 1 of each intervention period. This single center trial will be conducted in Russia. The overall time to participate in this study is 66 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
72
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
Yaroslavl, Russia
Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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