Healthy Volunteers Clinical Trial
Official title:
A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects
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.
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