At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
Alogliptin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Alogliptin, Pioglitazone, and 1 other intervention for Healthy Volunteers. Completed, enrolled 72 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartMay 2018
Primary CompletionJul 2018
TodayJul 2026
First PostedApr 18, 2018
Enrollment StartMay 26, 2018
Primary CompletionJul 11, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago
Interventions
Alogliptindrug
Alogliptin tablets.
Pioglitazonedrug
Pioglitazone tablets.
SYR-322-4833 BLdrug
SYR-322-4833 BL FDC tablets.