CompletedPhase 1

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

Brazil284 participantsStarted 2017-09-26

Plain-language summary

This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated, written informed consent prior to any study-specific procedures
. Healthy male and female subjects aged 18 - 50 years with suitable veins for cannulation or repeated venipuncture
. Females must have a negative serum pregnancy test at screening and negative urine pregnancy test on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
. Have a body mass index (BMI) between 18.50 and 24.90 kg/m2 inclusive \[15% variance on the upper limit is permitted (i.e., up to 28.63 kg/m2)\] and weigh between 50 and 100 kg inclusive at screening

Exclusion criteria

. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
. 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP
. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state

Timeframe: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times

Part 2 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state

Timeframe: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times

Part 1 - Peak Plasma Concentration (Cmax) for each analyte and each state

Timeframe: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times

Part 2 - Peak Plasma Concentration (Cmax) for each analyte and each state

Timeframe: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times

Trial details

NCT IDNCT03216278

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-22

View on ClinicalTrials.gov More Healthy Subjects in Fasted and Fed State trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated, written informed consent prior to any study-specific procedures
. Healthy male and female subjects aged 18 - 50 years with suitable veins for cannulation or repeated venipuncture
. Females must have a negative serum pregnancy test at screening and negative urine pregnancy test on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
. Have a body mass index (BMI) between 18.50 and 24.90 kg/m2 inclusive \[15% variance on the upper limit is permitted (i.e., up to 28.63 kg/m2)\] and weigh between 50 and 100 kg inclusive at screening

Exclusion criteria

. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
. 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP
. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator