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.

Age range18 Years – 50 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Any clinically significant abnormal findings in vital signs, as judged by the investigator
✕. Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) as judged by the investigator
✕. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody
✕. Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN

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

NCT IDNCT03216278

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-22

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Any clinically significant abnormal findings in vital signs, as judged by the investigator
✕. Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) as judged by the investigator
✕. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody
✕. Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN