CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 112 enrolled
Drug / intervention
Saxagliptin/metformin fixed-dose combination (FDC) +4 moredrug
Likely dose
Saxagliptin/metformin fixed-dose combination (FDC) 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.

Search/NCT01365091
NCT01365091Phase 1Completed
CompareCT.gov

Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States

AstraZeneca·interventional·Posted Jun 3, 2011·Updated May 8, 2015

In Brief

A Phase 1 clinical trial evaluating Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 112 participants across 1 site.

Detailed Summary

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.1 years ago

Interventions

Saxagliptin/metformin fixed-dose combination (FDC)drug

Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

Saxagliptindrug

Tablet, oral, 5 mg, once on Day 1 only, 1 day

Metformin extended-release (XR)drug

Tablet, oral, 500 mg, once on Day 1 only, 1 day

Saxagliptin/Metformin FDCdrug

Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

Metformindrug

Tablet, oral, 1000 mg, once on Day 1 only, 1 day