CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
saxagliptin +2 moredrug
Likely dose
saxagliptin 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/NCT01192139
NCT01192139Phase 1Completed
CompareCT.gov

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition

AstraZeneca·interventional·Posted Aug 31, 2010·Updated May 21, 2015

In Brief

A Phase 1 clinical trial evaluating saxagliptin, metformin XR, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \[IN\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2010
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.8 years ago

Interventions

saxagliptindrug

Tablets, Oral, 5 mg, once daily, Single dose

metformin XRdrug

Tablets, Oral, 500 mg. once daily, Single dose

saxagliptin + metformin XR (FDC tablet)drug

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose