Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
Yaroslavl, 150047, Russia
NCT Number: NCT03501277
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Yaroslavl, 150047, Russia
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Other names: Incresync
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Takeda
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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