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 850 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 850 mg Metformin (Glucophage Marketed by Merck Serono) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed Conditions
In Brief
A Phase 1 clinical trial evaluating saxagliptin, metformin, 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/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionMar 2010
TodayJul 2026
First PostedFeb 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.4 years ago
Interventions
saxagliptindrug
Tablets, Oral, 2.5 mg, once daily, single dose
metformindrug
Tablets, Oral, 850 mg, once daily, single dose
saxagliptin + metformin (FDC tablet)drug
Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose