CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) +3 moredrug
Likely dose
dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)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/NCT02637037
NCT02637037Phase 1Completed
CompareCT.gov

A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants in Healthy Subjects Under Fasting and Fed Conditions

AstraZeneca·interventional·Posted Dec 22, 2015·Updated Mar 13, 2018

In Brief

A Phase 1 clinical trial evaluating dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), and 2 other interventions for Bioequivalence and 2 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartDec 21, 2015
Primary CompletionApr 7, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.5 years ago

Interventions

dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)drug

single fixed-combination dose tablets

dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)drug

single fixed-dose combination tablets

dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)drug

single fixed-dose combination tablets

dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)drug

single fixed-dose combination tablets