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This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose |
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| Treatment B | Active Comparator | Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose |
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| Treatment C | Experimental | Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose |
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| Treatment D | Active Comparator | Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose |
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| Treatment E | Experimental | Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) | Drug | single fixed-combination dose tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state. | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State. | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (t Max) | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male and female subjects aged 18 - 55 years with suitable veins for cannulation or repeated venipuncture
Females must have a negative serum pregnancy test at screening and 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 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, MDCM, M.Sc, CPI | PAREXEL Early Phase Clinical Unit Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21225 | United States |
Sequences 1, 2, 3 and 4 Part 1: ABCD, BADC, ABDC, BACD Part 2: EFGH, FEHG, EFHG, FEGH (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted; E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) A total of 80 subjects were randomized into the study
This study was conducted at PAREXEL International, Early Phase Clinical Unit Baltimore, United States of America. Subjects were randomized into 4-period, 4-treatment (per study part) crossover (4 sequences containing 4 treatments) in fed and fasted state.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 | Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Treatment F | Active Comparator | Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose |
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| Treatment G | Experimental | Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose |
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| Treatment H | Active Comparator | Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose |
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| dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) | Drug | single fixed-dose combination tablets |
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| dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon) | Drug | single fixed-dose combination tablets |
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| dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao) | Drug | single fixed-dose combination tablets |
|
| Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
| FG001 |
| Part 2 |
Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg) |
| BG001 | Part 2 | Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state. | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Primary | AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State. | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Primary | Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State | To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Secondary | Time to Reach Maximum Plasma Concentration (t Max) | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Median | Full Range | Hour | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Secondary | Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Mean | Standard Deviation | Hour (h) | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Secondary | Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Mean | Standard Deviation | L/h | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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| Secondary | Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F] | To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states. | PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data. | Posted | Mean | Standard Deviation | L | Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period |
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From screening until 72 hours postdose for each treatment period (ie. visit 1 to visit 6).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant | 0 | 40 | 2 | 40 | ||
| EG001 | Treatment B | Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant | 0 | 38 | 5 | 38 | ||
| EG002 | Treatment C | Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant | 0 | 37 | 1 | 37 | ||
| EG003 | Treatment D | Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant | 0 | 36 | 2 | 36 | ||
| EG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant | 0 | 39 | 2 | 39 | ||
| EG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant | 0 | 40 | 4 | 40 | ||
| EG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant | 0 | 39 | 4 | 39 | ||
| EG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant | 0 | 39 | 3 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca AB | +46 31 7761000 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Male |
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| Metformin |
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| Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D. | Ratios of Geometric means | 0.99 | 2-Sided | 90 | 0.96 | 1.01 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F. | Ratios of Geometric means | 0.97 | 2-Sided | 90 | 0.94 | 1.00 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H. | Ratios of Geometric means | 0.98 | 2-Sided | 90 | 0.95 | 1.00 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B. | Ratios of Geometric means | 1.01 | 2-Sided | 90 | 0.96 | 1.06 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D. | Ratios of Geometric means | 1.00 | 2-Sided | 90 | 0.93 | 1.07 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F. | Ratios of Geometric means | 1.05 | 2-Sided | 90 | 0.99 | 1.11 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H. | Ratios of Geometric means | 1.03 | 2-Sided | 90 | 0.96 | 1.10 | Non-Inferiority or Equivalence | If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent. |
| OG003 |
| Treatment D |
Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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| Treatment D |
Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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|
Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG004 | Treatment E | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG005 | Treatment F | Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
| OG006 | Treatment G | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant |
| OG007 | Treatment H | Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant |
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