Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

NCT02577315 | Completed Phase 1 Results

• 1 other identifier: 1276.27
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

• Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

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

  Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

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

  Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

Secondary Outcomes (2)

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

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

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

  PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

Study Arms (2)

Test - Empagliflozin/Metformin

EXPERIMENTAL

fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions

Drug: Empagliflozin; Drug: Metformin

Reference - Empagliflozin + Metformin

EXPERIMENTAL

free combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of water under fed conditions

Drug: Empagliflozin; Drug: Metformin

Interventions

Empagliflozin DRUG

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

Test - Empagliflozin/Metformin

Metformin DRUG

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

Test - Empagliflozin/Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects aged 18 to 45 years and BMI 18.50 to 24.99 kg/m2 by Quetelet
• Signed informed consent prior to admission to the study
• Subjects must be able to undergo all trial related requests and procedures and follow any trial related restrictions on concomitant medications, diet and life style
• Subjects must be never-smokers or ex-smokers who stopped smoking prior to enrolment (Visit 1)
• Male or female subjects using adequate contraception from at least 30 days before the first study drug administration and until 30 days after trial completion

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and any laboratory value outside the reference range
• Positive results of blood tests for infections (HIV, Syphilis, Hepatitis B or C), urine drug screening test and alcohol breath test
• Any evidence of a concomitant disease judged clinically relevant by the investigator and presence of cardiovascular, respiratory, nervous, endocrine, reproductive, hematopoietic, immune system disorders; gastrointestinal, hepatic, urinary tract, hepatobiliary disorder, mental disturbance
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drugs (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Regular use of medicinal products less than 2 weeks before investigational drug administration
• Intake of systemic inhibitors or inductors of microsomal hepatic enzymes in less than 30 days before investigational drug administration
• Intake of drugs with a long half-life (¿24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Use of drugs which might reasonably influence the results of the trial based on current knowledge within 14 days prior to drug administration or during the trial
• Participation in another trial with investigational drug administration within 3 months prior to administration of trial medication
• Alcohol intake = 10 units of alcohol per week (1 unit of alcohol equals one 50 ml single measure of distilled alcoholic beverages/spirits (ABV 40%), or 0.5 litre of beer (ABV 5%), or 200 ml glass or red wine (ABV 12%) or history of alcohol abuse, narcomania, or other drug abuse.
• Drug abuse
• Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1276.27.001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

MeSH Terms

Interventions

empagliflozin; Metformin

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: 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 8, 2015
• First Posted: October 16, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 30, 2016
• Results First Posted: November 30, 2016

Record last verified: 2016-10

Locations

RU (1)