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2x Metformin

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Aug 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

2x Metformin clinical trials

2x Metformin · 1 trial · 1 indication

Phase 1 1
NCT01845077Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single TabletsHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Healthy
NCT0184507772
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Study Endpoints

Primary Endpoints

AUC0-72 of Linagliptin
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

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.

Cmax of Linagliptin
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

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.

AUC0-tz of Metformin
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

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.

Cmax of Metformin
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

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.

Secondary Endpoints

AUC0-infinity of Linagliptin
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
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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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5 mg Linagliptin/1000 mg Metformin, fedACTIVE_COMPARATOR3 single tablets under fed conditions
5 mg Linagliptin/1500 mg Metformin FDCEXPERIMENTAL2 FDC tablets under fasted conditions
5 mg Linagliptin/1500 mg MetforminACTIVE_COMPARATOR4 single tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin FDCEXPERIMENTAL1 fixed dose combination(FDC) tablet under fasted conditions
5 mg Linagliptin/1000 mg MetforminACTIVE_COMPARATOR3 single tablets under fasted conditions
5mg Linagliptin/1000mg Metformin, FDCfedEXPERIMENTAL1 FDC tablet under fed conditions

Interventions

NameTypeDescription
2x500 mg Metformin (Glumetza)DRUG2 tablets
5 mg Linagliptin/1000 mg Metformin FDCDRUGFDC tablet
5 mg Linagliptin (Tradjenta)DRUG1 tablet
3x500 mg Metformin (Glumetza)DRUG3 tablets
2 x 500 mg Metformin (Glumetza)DRUG2 tablets
5 mg Linagliptin/1000mg Metformin FDCDRUGFDC Tablet
2 x 2.5 mg Linagliptin/750 mg Metformin FDCDRUG2 FDC tablets
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: 1. Healthy males or females 2. Age 18 -50 years (incl) 3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) 4. Subjects must be able to understand and comply with study requirements Exclusion criteria: Any deviation from healthy condition

Countries:United States
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