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

NCT ID: NCT02028767

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fixed Dose Combination (FDC)

12.5 mg Empagliflozin / 500mg metformin fixed dose combination

Group Type: EXPERIMENTAL

Empagliflozin/Metformin FDC

Intervention Type: DRUG

12.5 mg Empagliflozin / 500 mg Metformin

Separate tablets

Empagliflozin and Metformin tablets

Group Type: ACTIVE_COMPARATOR

Empagliflozin 2.5 mg

Intervention Type: DRUG

Empagliflozin 2.5 mg tablet

Empagliflozin 10 mg

Intervention Type: DRUG

Empagliflozin 10 mg tablet

Metformin 500 mg

Intervention Type: DRUG

Metformin 500 mg tablet

Interventions

Empagliflozin 2.5 mg

Empagliflozin 2.5 mg tablet

Intervention Type: DRUG

Empagliflozin 10 mg

Empagliflozin 10 mg tablet

Intervention Type: DRUG

Metformin 500 mg

Metformin 500 mg tablet

Intervention Type: DRUG

Empagliflozin/Metformin FDC

12.5 mg Empagliflozin / 500 mg Metformin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age 18 to 50 years (inclusive)

3. BMI 18.5 to 29.9 kg/m2 (inclusive)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion Criteria

1. 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.

2. Any evidence of a concomitant disease judged clinically relevant by the investigator.

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.

4. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

5. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders.

6. History of relevant orthostatic hypotension, fainting spells, or blackouts.

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to the trial medication or it's excipients)

9. 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.

10. 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

11. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication.

12. Smoker (has used tobacco or nicotine-containing products within 6 months prior to administration of trial medication)

13. Inability to refrain from smoking on specified trial days

14. Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or > 7 alcohol-containing drinks per week)

15. Drug abuse or positive drug screen

16. Blood donation (more than 100 ml wihtin 30 days prior to administration of trial medication or intended during the trial)

17. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

18. Inability to comply with dietary regimen of trial site

19. Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study.

For female subjects:

20. Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion.

21. No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent, surgically sterile, or post menopausal will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide). Post-menopausal is defined as at least 1 year of spontaneous amenorrhea and deemed post menopausal by a physician based on screening clinical laboratory tests (follicle stimulating hormone and luteinizing hormone).

22. Lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1276.24.001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1276.24

Identifier Type: -

Identifier Source: org_study_id