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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin & metformin and the single tablets of linagliptin and metformin when administered singularly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Linagliptin/1000 mg Metformin, fed | Active Comparator | 3 single tablets under fed conditions |
|
| 5 mg Linagliptin/1500 mg Metformin FDC | Experimental | 2 FDC tablets under fasted conditions |
|
| 5 mg Linagliptin/1500 mg Metformin | Active Comparator | 4 single tablets under fasted conditions |
|
| 5 mg Linagliptin/1000 mg Metformin FDC | Experimental | 1 fixed dose combination(FDC) tablet under fasted conditions |
|
| 5 mg Linagliptin/1000 mg Metformin | Active Comparator | 3 single tablets under fasted conditions |
|
| 5mg Linagliptin/1000mg Metformin, FDCfed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2x500 mg Metformin (Glumetza) | Drug | 2 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72 of Linagliptin | Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| Cmax of Linagliptin | Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| AUC0-tz of Metformin | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| Cmax of Metformin | Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity of Linagliptin | Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. |
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Inclusion criteria:
Exclusion criteria:
Any deviation from healthy condition
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1288.8.1 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FDC1000 Fasted, Then L+M1000 Fasted | 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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| Experimental |
1 FDC tablet under fed conditions |
|
| 5 mg Linagliptin/1000 mg Metformin FDC |
| Drug |
FDC tablet |
|
| 5 mg Linagliptin (Tradjenta) | Drug | 1 tablet |
|
| 5 mg Linagliptin (Tradjenta) | Drug | 1 tablet |
|
| 3x500 mg Metformin (Glumetza) | Drug | 3 tablets |
|
| 5 mg Linagliptin (Tradjenta) | Drug | 1 tablet |
|
| 2 x 500 mg Metformin (Glumetza) | Drug | 2 tablets |
|
| 5 mg Linagliptin/1000mg Metformin FDC | Drug | FDC Tablet |
|
| 2 x 2.5 mg Linagliptin/750 mg Metformin FDC | Drug | 2 FDC tablets |
|
| 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| AUC0-infinity of Metformin | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| FG001 | L+M1000 Fasted, Then FDC1000 Fasted | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| FG002 | FDC1000 Fed, Then L+M1000 Fed | 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| FG003 | L+M1000 Fed, Then FDC1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| FG004 | FDC1500 Fasted, Then L+M1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| FG005 | L+M1500 Fasted, Then FDC1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Washout Period |
|
|
| Treatment Period 2 |
|
Treated set (TS) including all subjects who had been dispensed study medication and were documented to have taken at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total 1000 Fasted | Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| BG001 | Total 1000 Fed | Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| BG002 | Total 1500 Fasted | Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 | AUC0-72 of Linagliptin | Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cmax of Linagliptin | Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-infinity of Linagliptin | Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-infinity of Metformin | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | AUC0-tz of Metformin | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cmax of Metformin | Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means. | Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period |
|
8 weeks
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FDC1000 Fasted | 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. | 0 | 23 | 1 | 23 | ||
| EG001 | L+M1000 Fasted | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. | 0 | 23 | 1 | 23 | ||
| EG002 | FDC1000 Fed | 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. | 0 | 22 | 1 | 22 | ||
| EG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. | 1 | 23 | 0 | 23 | ||
| EG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. | 0 | 23 | 3 | 23 | ||
| EG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions | 0 | 23 | 2 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Adverse Event |
|
| elevated lab values (not clinic. sign.) |
|
| Protocol Violation |
|
| Male |
|
| One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment. | ANOVA | ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects. | Ratio of geometric means | 101.5 | 2-Sided | 90 | 98.4 | 104.7 | Yes | Non-Inferiority or Equivalence | Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory. |
| ANOVA | ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects. | Ratio of geometric means | 100.9 | 2-Sided | 90 | 98.2 | 103.7 | Yes | Non-Inferiority or Equivalence | Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory. |
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
| OG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
|
|
|
| OG002 | FDC1000 Fed | 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
| OG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions |
|
|
|
| OG002 | FDC1000 Fed | 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
| OG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions |
|
|
|
| OG002 |
| FDC1000 Fed |
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
| OG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions |
|
|
|
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG003 | L+M1000 Fed | 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions. |
| OG004 | FDC1500 Fasted | 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
| OG005 | L+M1500 Fasted | 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions. |
|
|
|