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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin + Glucophage tablet fed; Drug: Dapagliflozin/metformin IR FDC tablet fed; Drug: Dapagliflozin + Glucophage tablet fasted; Drug: Dapagliflozin/metformin IR FDC tablet fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT01535677

D1691C00007

Details and patient eligibility

About

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.

Full 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

Enrollment: 71 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 4 patient groups

1

Experimental group

Description:

5 mg dapagliflozin and 850 mg Glucophage in fasted state

Treatment:

Drug: Dapagliflozin + Glucophage tablet fasted

2

Experimental group

Description:

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

Treatment:

Drug: Dapagliflozin/metformin IR FDC tablet fasted

3

Experimental group

Description:

5 mg dapagliflozin and 850 mg Glucophage in fed state

Treatment:

Drug: Dapagliflozin + Glucophage tablet fed

4

Experimental group

Description:

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

Treatment:

Drug: Dapagliflozin/metformin IR FDC tablet fed