Skip to main content
OpenTrials
Completed

NCT Number: NCT01535677

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin + Glucophage tablet fasted

Drug

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

Dapagliflozin/metformin IR FDC tablet fasted

Drug

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

Dapagliflozin + Glucophage tablet fed

Drug

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

Dapagliflozin/metformin IR FDC tablet fed

Drug

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

Primary outcomes

  1. Area under the curve over the time (AUC)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  2. AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t))

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  3. Maximum concentration (Cmax)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

Secondary outcomes

  1. Time to reach maximum analyte concentration (tmax)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  2. Terminal rate constant (λz)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  3. Time of last quantifiable analyte concentration (tlast)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  4. Terminal half-life (t1/2)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  5. Observed maximum analyte concentration (Cmax)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  6. Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  7. Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t))

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  8. Elimination terminal half-life (t1/2)

    Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

    No statistical analysis will be performed

  9. Safety profile description in term of Adverse Events

    Time frame: from first dose in treatment period 1 up to 10 days after final dose

    No statistical analysis will be performed

  10. Safety profile description in term of Blood Pressure

    Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose

    No statistical analysis will be performed

  11. Safety profile description in term of Physical Examination

    Time frame: at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose

    No statistical analysis will be performed

  12. Safety profile description in term of Electrocardiogram ECG

    Time frame: at screening and up to 10 days after final dose

    No statistical analysis will be performed

  13. Safety profile description in term of Heart Rate

    Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose

    No statistical analysis will be performed

  14. Safety profile description in term of Safety Labs

    Time frame: at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose

    No statistical analysis will be performed

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.