Healthy Subjects in Fasted and Fed StatePhase 1NCT03216278
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
A Phase 1 study testing Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg and Dapagliflozin/metformin XR 10/1000mg in people with Healthy Subjects in Fasted and Fed State, run by AstraZeneca at 1 site in Brazil.
Trial summary
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects in Fasted and Fed State
- What is being tested?
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg and Dapagliflozin/metformin XR 10/1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2017to 22 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post menopausal range
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- Known or suspected history of drug abuse, as judged by the investigator
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose.
- Note: Subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to dapagliflozin/metformin XR.
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
- Positive screen for drugs of abuse or alcohol at screening or on each admission to the study center
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life Note: Hormonal replacement therapy is allowed for females.
- Known or suspected history of alcohol abuse or excessive intake of alcohol, as judged by the investigator
- Inclusion of any AstraZeneca or study site employee or their close relatives
- Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
Read the detailed description
This is a two part, open-label, randomized, 4-period, 4-treatment (per study part) crossover study in healthy subjects (males and females of non-childbearing potential), performed at a single study center, conducted to establish the bioequivalence of 2 strengths of dapagliflozin/metformin XR tablets manufactured at two different plants.
- Conditions
- Healthy Subjects in Fasted and Fed State
- Being tested
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 10/1000mg
- Keywords
- healthy,, fasted,, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin/metformin XR 5/500mgDrug
Also called Mt Vernon plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 5/500 mgDrug
Also called Humacao plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 5/500mgDrug
Also called Dapagliflozin/metformin XR 5/500mg Mount Vernon plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 5/500mgDrug
Also called Humacao plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 10/1000mgDrug
Also called Mount Vernon plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 10/1000mgDrug
Also called Humacao plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 10/1000mgDrug
Also called Dapagliflozin/metformin XR 10/1000mg Mount Vernon plant
Tablets for oral administration, once daily, once per treatment period
Dapagliflozin/metformin XR 10/1000mgDrug
Also called Dapagliflozin/metformin XR 10/1000mg Humacao plant
Tablets for oral administration, once daily, once per treatment period
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fed Receives: Drug: Dapagliflozin/metformin XR 5/500mg |
| Treatment B | Active comparator | Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fed Receives: Drug: Dapagliflozin/metformin XR 5/500 mg |
| Treatment C | Experimental | Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fasted Receives: Drug: Dapagliflozin/metformin XR 5/500mg |
| Treatment D | Active comparator | Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fasted Receives: Drug: Dapagliflozin/metformin XR 5/500mg |
| Treatment E | Experimental | Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fed Receives: Drug: Dapagliflozin/metformin XR 10/1000mg |
| Treatment F | Active comparator | Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fed Receives: Drug: Dapagliflozin/metformin XR 10/1000mg |
| Treatment G | Experimental | Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fasted Receives: Drug: Dapagliflozin/metformin XR 10/1000mg |
| Treatment H | Active comparator | Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fasted Receives: Drug: Dapagliflozin/metformin XR 10/1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Measured: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Measured: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Measured: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Measured: 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
Secondary outcomes (13)
Area under plasma concentration - time curve from time zero to infinity (AUC)
Measurements of AUC from time zero to infinity for dapagliflozin and metformin when administered as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states.
Measured: 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
Adverse events
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing the number of subjects with adverse events.
Measured: 10,5 weeks
Blood pressure
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in mmHg of systolic and diastolic blood pressure.
Measured: 10,5 weeks
Electrocardiogram (ECG)
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in overall ECG evaluation.
Measured: 10,5 weeks
Time to reach maximum plasma concentration (tmax)
Measurements of tmax for dapagliflozin and metformin when administered in both fed and fasted states as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants.
Measured: 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
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Measurements of half-life associated with terminal slope (t½λz) for dapagliflozin and metformin when administered in both fed and fasted states as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants.
Measured: 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
Terminal elimination rate constant (λz)
Measurements of terminal elimination rate constant (λz) for dapagliflozin and metformin when administered in both fed and fasted states as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants.
Measured: 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
Apparent total body clearance after extravascular administration (CL/F)
Measurements of apparent total body clearance after extravascular administration (CL/F) for dapagliflozin and metformin when administered in both fed and fasted states as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants.
Measured: 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
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measurements of apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) for dapagliflozin and metformin when administered in both fed and fasted states as single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants.
Measured: 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
Laboratory assessments - hematology
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in hematology.
Measured: 10,5 weeks
Heart rate
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in heart rate measured as beats per minute.
Measured: 10,5 weeks
Laboratory assessments - clinical chemistry
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in clinical chemistry.
Measured: 10,5 weeks
Laboratory assessments - urinalysis
To evaluate the safety of single doses of dapagliflozin/metformin 5/500 mg or 10/1000 mg formulation from both the Mount Vernon and Humacao plants both fed and fasted states by assessing changes from baseline in urinalysis.
Measured: 10,5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start26 Sep 2017
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects in Fasted and Fed StateStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216278
- Sponsor's protocol ID
- D1691C00016
- Status last verified
- May 2018
- First submitted
- 7 Apr 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT03216278
- Acronym / sponsor ID
- D1691C00016
- Conditions
- Healthy Subjects in Fasted and Fed State
- Keywords
- healthy,, fasted,, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
Detailed description
This is a two part, open-label, randomized, 4-period, 4-treatment (per study part) crossover study in healthy subjects (males and females of non-childbearing potential), performed at a single study center, conducted to establish the bioequivalence of 2 strengths of dapagliflozin/metformin XR tablets manufactured at two different plants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Dapagliflozin/metformin XR 5/500mgDapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fed |
| Treatment B | Active comparator | Drug: Dapagliflozin/metformin XR 5/500 mgDapagliflozin/metformin XR 5/500 Humacao Reference Product Fed |
| Treatment C | Experimental | Drug: Dapagliflozin/metformin XR 5/500mgDapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fasted |
| Treatment D | Active comparator | Drug: Dapagliflozin/metformin XR 5/500mgDapagliflozin/metformin XR 5/500 Humacao Reference Product Fasted |
| Treatment E | Experimental | Drug: Dapagliflozin/metformin XR 10/1000mgDapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fed |
| Treatment F | Active comparator | Drug: Dapagliflozin/metformin XR 10/1000mgDapagliflozin/metformin XR 10/1000 Humacao Reference Product Fed |
| Treatment G | Experimental | Drug: Dapagliflozin/metformin XR 10/1000mgDapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fasted |
| Treatment H | Active comparator | Drug: Dapagliflozin/metformin XR 10/1000mgDapagliflozin/metformin XR 10/1000 Humacao Reference Product Fasted |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin/metformin XR 5/500mgAlso: Mt Vernon plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment A |
| Dapagliflozin/metformin XR 5/500 mgAlso: Humacao plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment B |
| Dapagliflozin/metformin XR 5/500mgAlso: Dapagliflozin/metformin XR 5/500mg Mount Vernon plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment C |
| Dapagliflozin/metformin XR 5/500mgAlso: Humacao plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment D |
| Dapagliflozin/metformin XR 10/1000mgAlso: Mount Vernon plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment E |
| Dapagliflozin/metformin XR 10/1000mgAlso: Humacao plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment F |
| Dapagliflozin/metformin XR 10/1000mgAlso: Dapagliflozin/metformin XR 10/1000mg Mount Vernon plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment G |
| Dapagliflozin/metformin XR 10/1000mgAlso: Dapagliflozin/metformin XR 10/1000mg Humacao plantTablets for oral administration, once daily, once per treatment period | Drug | Treatment H |
Primary outcome
Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
Time frame: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 2 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
Time frame: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 1 - Peak Plasma Concentration (Cmax) for each analyte and each state
Time frame: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 2 - Peak Plasma Concentration (Cmax) for each analyte and each state
Time frame: 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
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
13 secondary outcomes
Area under plasma concentration - time curve from time zero to infinity (AUC)
Time frame: 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
Adverse events
Time frame: 10,5 weeks
Blood pressure
Time frame: 10,5 weeks
Electrocardiogram (ECG)
Time frame: 10,5 weeks
Time to reach maximum plasma concentration (tmax)
Time frame: 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
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Time frame: 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
Terminal elimination rate constant (λz)
Time frame: 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
Apparent total body clearance after extravascular administration (CL/F)
Time frame: 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
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: 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
Laboratory assessments - hematology
Time frame: 10,5 weeks
Heart rate
Time frame: 10,5 weeks
Laboratory assessments - clinical chemistry
Time frame: 10,5 weeks
Laboratory assessments - urinalysis
Time frame: 10,5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Yes
Related trials for Healthy Subjects in Fasted and Fed State
Active, not recruitingPhase 1
Pharmacokinetics of Zelquistinel in Fasted or Fed State
Healthy Volunteers in Fed and Fasted State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg and Dapagliflozin/metformin XR 10/1000mg in people with Healthy Subjects in Fasted and Fed State, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.