Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

NCT01211197 | Completed Phase 1 Results

• 2 other identifiers: 1276.52010-018589-22
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

  Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV).

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Empa: Maximum Measured Concentration (Cmax)

  Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)

  Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Metformin: Maximum Measured Concentration (Cmax)

  Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary Outcomes (9)

• Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Time to Maximum Measured Concentration (Tmax)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Terminal Elimination Rate Constant in Plasma (λz)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

• Terminal Half-life in Plasma (T1/2)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Study Arms (3)

A

EXPERIMENTAL

3 treatments will be investigated in randomized order

Drug: A: BI 10773 / metformin tablet

B

EXPERIMENTAL

3 treatments will be investigated in randomized order

Drug: B: BI 10773 tablet and metformin tablet

C

EXPERIMENTAL

3 treatments will be investigated in randomized order

Drug: C: BI 10773 / metformin tablet

Interventions

C: BI 10773 / metformin tablet DRUG

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

C

B: BI 10773 tablet and metformin tablet DRUG

BI 10773 and metformin single tablets, administered together in fasted state

B

A: BI 10773 / metformin tablet DRUG

BI 10773 / metformin fixed dose combination tablet in fasted state

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria
• Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

You may not qualify if:

• Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1276.5.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: 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: September 28, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Last Updated: August 21, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-07

Locations

DE (1)