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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

NCT01055691

Healthy Volunteers

COMPLETED PHASE1

A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

NCT02637037

Bioequivalence Fixed Dose Combination Tablets Healthy Male and Female Subjects

COMPLETED PHASE1

A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.

NCT04856007

Healthy Volunteer

COMPLETED PHASE1

The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions

NCT03216278

Healthy Subjects in Fasted and Fed State

COMPLETED PHASE1

Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects

NCT03138356

Type 2 Diabetes Mellitus

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

5 mg dapagliflozin and 850 mg Glucophage in fasted state

Group Type EXPERIMENTAL

Dapagliflozin + Glucophage tablet fasted

Intervention Type DRUG

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

2

dapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted

Group Type EXPERIMENTAL

Dapagliflozin/metformin IR FDC tablet fasted

Intervention Type DRUG

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

3

5 mg dapagliflozin and 850 mg Glucophage in fed state

Group Type EXPERIMENTAL

Dapagliflozin + Glucophage tablet fed

Intervention Type DRUG

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

4

dapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state

Group Type EXPERIMENTAL

Dapagliflozin/metformin IR FDC tablet fed

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin + Glucophage tablet fasted

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

Intervention Type DRUG

Dapagliflozin/metformin IR FDC tablet fasted

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

Intervention Type DRUG

Dapagliflozin + Glucophage tablet fed

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

Intervention Type DRUG

Dapagliflozin/metformin IR FDC tablet fed

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy volunteers aged 18 to 55 years inclusive with suitable veins for cannulation or repeated vein puncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
* Non-pregnant, non-lactating female subjects who if pre-menopausal are using adequate birth control eg, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device (IUD)/intrauterine systems
* Have a body mass index (BMI) between 18.5 and 30.0 kg/m2 inclusive (ie, within 15% of normal range) and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria

* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with individual safety evaluation Current smokers who smoke more than 5 cigarettes per day (or equivalent use of tobacco products) or cannot give up smoking during the study
* Excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day)
* Plasma donation within one month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes