At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Saxagliptin +2 moredrug
Likely dose
Saxagliptin 2.5 mgfrom 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.
Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
In Brief
A Phase 1 clinical trial evaluating Saxagliptin, Metformin IR (glucophage), and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartJun 2009
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 12, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Saxagliptindrug
Tablet, Oral, 2.5 mg, Once Daily, 1 week
Metformin IR (glucophage)drug
Tablets, Oral, 1000 mg, Once Daily, 1 week
Saxagliptin + Metformin IR (FDC)drug
Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week