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CompletedNCT01535677Updated Jul 9, 2015

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

A Phase 1 interventional study of Dapagliflozin + Glucophage tablet fasted and Dapagliflozin/metformin IR FDC tablet fasted in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-09.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

Read the detailed description

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

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Phase 1
  • healthy volunteers
  • cross-over study
  • Bioavailability
  • Bioequivalence
  • Cmax
  • tmax
  • AUC
  • AUC(0-t)
  • λz
  • tlast
03

In context

Diabetes Mellitus, Type 2

9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 71 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    1

    5 mg dapagliflozin and 850 mg Glucophage in fasted state

    Drug: Dapagliflozin + Glucophage tablet fasted

  • Experimental
    2

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

    Drug: Dapagliflozin/metformin IR FDC tablet fasted

  • Experimental
    3

    5 mg dapagliflozin and 850 mg Glucophage in fed state

    Drug: Dapagliflozin + Glucophage tablet fed

  • Experimental
    4

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

    Drug: Dapagliflozin/metformin IR FDC tablet fed

Interventions

  • DrugDapagliflozin + Glucophage tablet fasted

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

  • DrugDapagliflozin/metformin IR FDC tablet fasted

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

  • DrugDapagliflozin + Glucophage tablet fed

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

  • DrugDapagliflozin/metformin IR FDC tablet fed

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

06

What researchers measure

Primary outcomes

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

    No statistical analysis will be performed

    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

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

    No statistical analysis will be performed

    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

  3. Maximum concentration (Cmax)

    No statistical analysis will be performed

    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

Secondary outcomes

  1. Time to reach maximum analyte concentration (tmax)

    No statistical analysis will be performed

    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

  2. Terminal rate constant (λz)

    No statistical analysis will be performed

    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

  3. Time of last quantifiable analyte concentration (tlast)

    No statistical analysis will be performed

    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

  4. Terminal half-life (t1/2)

    No statistical analysis will be performed

    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

  5. Observed maximum analyte concentration (Cmax)

    No statistical analysis will be performed

    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

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

    No statistical analysis will be performed

    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

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

    No statistical analysis will be performed

    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

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

    No statistical analysis will be performed

    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

  9. Safety profile description in term of Adverse Events

    No statistical analysis will be performed

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

  10. Safety profile description in term of Blood Pressure

    No statistical analysis will be performed

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

  11. Safety profile description in term of Physical Examination

    No statistical analysis will be performed

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

  12. Safety profile description in term of Electrocardiogram ECG

    No statistical analysis will be performed

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

  13. Safety profile description in term of Heart Rate

    No statistical analysis will be performed

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

  14. Safety profile description in term of Safety Labs

    No statistical analysis will be performed

    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

07

Study locations

1 site
  • Research Site
    London, United Kingdom
08

References and documents

Publications

  • Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW. Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004. Epub 2015 Jun 3. PubMed 26048185 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01535677
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 20, 2012
Start date
Apr 2013
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 9, 2015

Study contacts

Eva Johnsson, MD
study director · AstraZeneca Research and Development SE-431 83 Mölndal Sweden
Saeed Kahn, MBBS
principal investigator · Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR
Mirjana Kujacic, PHD
study chair · AstraZeneca Research and DevelopmentSE-431 83 Mölndal Sweden
View the source record on ClinicalTrials.gov ↗

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