Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted; Drug: Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

• Registration Number: NCT02821910
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-04
• Study Start: 2016-07-20
• Primary Completion: 2016-10-01
• Study Completion: 2016-10-31
• Status Verified: 2020-02
• Results First Submitted: 2020-02-06
• Results First Submitted QC: 2020-02-06
• Results First Posted: 2020-02-21
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose, fed	1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
High dose, fasted	1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions
High dose, fed	High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
High dose, fasted	High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions
Low dose, fed	Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
Low dose, fed	1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of Metformin in Plasma (Cmax)	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) is presented
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)	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 Linagliptin in plasma (Cmax) is presented
Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)	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) is presented
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)	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 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; * The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis); * A pre-dose concentration was \>5% of the Cmax value measured in that subject; * Missing samples or concentration data at important phases of PK disposition curve
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)	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) is presented
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)	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) is presented

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	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 Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	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-∞) is presented
Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	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-∞) is presented

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany