Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers

Inclusion criteria

• Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead ECG, clinical laboratory tests
• Age 18 to 55 years (inclusive)
• Body mass index (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 the local legislation

Exclusion criteria

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
• Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
• Any laboratory value outside the reference range of clinical relevance
• Inability to comply with dietary regimen of trial site

For female subjects of childbearing potential only:

• Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
• No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were asked to use an additional barrier method (e.g. condom).
• Lactation