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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005082-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose, fed | Experimental | 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions |
|
| High dose, fasted | Experimental | 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions |
|
| Low dose, fed | Experimental | 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed | Drug | High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented. Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example
| 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Maximum Measured Concentration of Empagliflozin in Plasma (Cmax) | Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Maximum Measured Concentration of Metformin in Plasma (Cmax) | Maximum measured concentration of Metformin in plasma (Cmax) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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Inclusion criteria:
Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
The subjects were randomly allocated to the 2 treatment sequences (test (T) - reference (R) or R-T) in 3 separate trial parts. There was a wash-out period of at least 35 days between the treatments.Treatments were administered as single doses in the fed state in Parts 1 and 3, and in the fasted state in Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1) | Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR | Drug | 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets |
|
| High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted | Drug | High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet |
|
| 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR | Drug | 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets |
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| Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed | Drug | Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet |
|
| 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR | Drug | 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets |
|
| Maximum Measured Concentration of Linagliptin in Plasma (Cmax) | Maximum measured concentration of Linagliptin in plasma (Cmax) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) | Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
| FG001 | E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1) | Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| FG002 | FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2) | Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h |
| FG003 | E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h |
| FG004 | FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
| FG005 | E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3) | Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| COMPLETED |
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| NOT COMPLETED |
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Treated set (TS): This subject set included all randomised subjects, whether treated or not, who were documented to have received at least 1 dose of study drug. This is the full analysis set population in the sense of ICH E9.
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| ID | Title | Description |
|---|---|---|
| BG000 | FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1) | Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
| BG001 | E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1) | Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| BG002 | FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2) | Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h |
| BG003 | E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h |
| BG004 | FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
| BG005 | E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3) | Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| BG006 | 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 |
| |||||||||||||||
| 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 the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented. Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example
| Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects in the TS who provided at least 1 primary or secondary PK parameter that was not excluded according to the criterion's for non-evaluable above. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles (nmol)*hours (h)/litres (L) | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Primary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms (ng)*h/ milliliter (mL) | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Primary | Maximum Measured Concentration of Empagliflozin in Plasma (Cmax) | Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Primary | Maximum Measured Concentration of Metformin in Plasma (Cmax) | Maximum measured concentration of Metformin in plasma (Cmax) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Primary | Maximum Measured Concentration of Linagliptin in Plasma (Cmax) | Maximum measured concentration of Linagliptin in plasma (Cmax) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Primary | Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) | Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the Linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration |
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Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
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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 | FDC 25 Fed (T1) | Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | 0 | 15 | 5 | 15 | ||
| EG001 | E25+L5+M1000 Fed (R1) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast | 0 | 14 | 4 | 14 | ||
| EG002 | FDC 25 Fast (T2) | Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h | 0 | 20 | 6 | 20 | ||
| EG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h | 0 | 18 | 4 | 18 | ||
| EG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | 0 | 14 | 1 | 14 | ||
| EG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast | 0 | 15 | 4 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Blister rupture | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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| Male |
|
| The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | ratio (%) | 100.80 | Standard Deviation | 4.8 | 2-Sided | 90 | 97.99 | 103.70 | Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV). | Superiority or Other (legacy) |
| The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | ratio (%) | 99.83 | Standard Deviation | 5.9 | 2-Sided | 90 | 95.96 | 103.85 | Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV). | Superiority or Other (legacy) |
| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 |
| E25+L5+M1000 Fast (R2) |
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 |
| E25+L5+M1000 Fast (R2) |
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| OG003 | E25+L5+M1000 Fast (R2) | Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h |
| OG004 | FDC 10 Fed (T3) | Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast |
| OG005 | E10+L5+M1000 Fed (R3) | Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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