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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Empagliflozin; Metformin

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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

• Relevant chronic or aAcute infections/ acute diseases occurred within 4 weeks before inclusion into the study

• 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

• Inability to comply with dietary regimen as per protocol and per protocol procedures

• 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

• Intake of xanthine-containing drinks or foods and alcohol from 72 h before screening and second treatment period

• Intake of drinks or foods containing grapefruits, Chinese grapefruits, Seville oranges for female subjects:

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

• Breast feeding