CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) +3 moredrug
Likely dose
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)from 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.

Search/NCT01068717
NCT01068717Phase 1Completed
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Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

AstraZeneca·interventional·Posted Feb 15, 2010·Updated May 12, 2015

In Brief

A Phase 1 clinical trial evaluating Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state), and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 27 participants across 1 site.

Detailed Summary

To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 16.4 years ago

Interventions

Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)drug

Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week

Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)drug

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week