CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Co-administration of Saxagliptin and Metformin IR, Fasted +3 moredrug
Likely dose
Co-administration of Saxagliptin and Metformin IR, Fasted 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.

Search/NCT00899470
NCT00899470Phase 1Completed
CompareCT.gov

Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 500 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State

AstraZeneca·interventional·Posted May 12, 2009·Updated Jun 1, 2015

In Brief

A Phase 1 clinical trial evaluating Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 24 participants across 1 site.

Detailed Summary

To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 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 12, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.1 years ago

Interventions

Co-administration of Saxagliptin and Metformin IR, Fasteddrug

Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions

Saxagliptin/Metformin, Fastingdrug

Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions

Co-administration of Saxagliptin and Metformin IR, Feddrug

Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions

Saxagliptin/Metformin, Feddrug

Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions