Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

NCT02028767 | Completed Phase 1 Results

• 1 other identifier: 1276.24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

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

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

• Cmax (Maximum Measured Concentration of Metformin in Plasma)

  Cmax (maximum measured concentration of metformin in plasma)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary Outcomes (1)

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

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Study Arms (2)

Fixed Dose Combination (FDC)

EXPERIMENTAL

12.5 mg Empagliflozin / 500mg metformin fixed dose combination

Drug: Empagliflozin/Metformin FDC

Separate tablets

ACTIVE COMPARATOR

Empagliflozin and Metformin tablets

Drug: Empagliflozin 2.5 mg; Drug: Empagliflozin 10 mg; Drug: Metformin 500 mg

Interventions

Empagliflozin 2.5 mg DRUG

Empagliflozin 2.5 mg tablet

Separate tablets

Empagliflozin 10 mg DRUG

Empagliflozin 10 mg tablet

Separate tablets

Metformin 500 mg DRUG

Metformin 500 mg tablet

Separate tablets

Empagliflozin/Metformin FDC DRUG

12.5 mg Empagliflozin / 500 mg Metformin

Fixed Dose Combination (FDC)

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 according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests.
• Age 18 to 50 years (inclusive)
• BMI 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation.

You may not qualify if:

• Any finding in the medical examination (Including blood pressure \[BP\], pulse rate \[PR\], or electrocardiogram \[ECG\]) deviating from normal and judged clinically relevant by the investigator.
• Any evidence of a concomitant disease judged clinically relevant by the investigator.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders.
• History of relevant orthostatic hypotension, fainting spells, or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or it's excipients)
• 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.
• Within 14 days prior to the administration of trial medication, use of drugs that might reasonably influence the results of the trial, based on current knowledge
• Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication.
• Smoker (has used tobacco or nicotine-containing products within 6 months prior to administration of trial medication)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or \> 7 alcohol-containing drinks per week)
• Drug abuse or positive drug screen

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1276.24.001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 24, 2015
• Results First Posted: July 24, 2015

Record last verified: 2015-06

Locations

CA (1)