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

NCT01975220 | Completed Phase 1 Results

• 1 other identifier: 1276.13
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin

  Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

• AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin

  AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

• Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin

  Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

• Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin

  Cmax (maximum measured concentration of the analyte in plasma); Metformin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Secondary Outcomes (2)

• AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

• AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Study Arms (3)

High dose, fasted

EXPERIMENTAL

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions

Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

High dose, fed

EXPERIMENTAL

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions

Drug: Empagliflozin/Metformin XR, FDC; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

Low dose, fasted

EXPERIMENTAL

2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions

Drug: Empagliflozin/Metformin XR FDC; Drug: 1 tablet Empagliflozin/3 tablets Metformin XR

Interventions

Empagliflozin/Metformin XR FDC DRUG

Experimental: low dose empagliflozin/metformin XR, FDC tablet

Low dose, fasted

25 mg Empagliflozin/1000 mg Metformin XR, FDC DRUG

Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

High dose, fasted

1 tablet Empagliflozin/2 tablets Metformin XR DRUG

Active Comparator: 1x empagliflozin/2x metformin XR tablets

High dose, fasted

1 tablet Empagliflozin/3 tablets Metformin XR DRUG

Active Comparator: 1x empagliflozin/3x metformin XR tablets

Low dose, fasted

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females
• Age 18-50 years (incl)
• Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
• Subjects must be able to understand and comply with study requirements

You may not qualify if:

• Any deviation from healthy condition

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

1276.13.1 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

MeSH Terms

Interventions

empagliflozin

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 8, 2017
• Results First Posted: March 8, 2017

Record last verified: 2016-08

Locations

US (1)