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To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately

NCT01535677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-07-09

No results posted yet for this study

Summary

This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.

Conditions

Interventions

DRUG

Dapagliflozin + Glucophage tablet fasted

Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state

DRUG

Dapagliflozin/metformin IR FDC tablet fasted

single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state

DRUG

Dapagliflozin + Glucophage tablet fed

Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state

DRUG

Dapagliflozin/metformin IR FDC tablet fed

single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state

Sponsors & Collaborators

Principal Investigators

  • Eva Johnsson, MD · AstraZeneca Research and Development SE-431 83 Mölndal Sweden

  • Saeed Kahn, MBBS · Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR

  • Mirjana Kujacic, PHD · AstraZeneca Research and DevelopmentSE-431 83 Mölndal Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535677 on ClinicalTrials.gov