Relative Bioavailability of a Linagliptin+Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects

NCT ID: NCT02223026

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

Brief Summary

Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet

Conditions

Healthy

Study Design

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

Study Groups

Linagliptin/metformin fed

Group Type: EXPERIMENTAL

Linagliptin/metformin FDC

Intervention Type: DRUG

high-fat, high caloric meal

Intervention Type: OTHER

Linagliptin/metformin fasted

Group Type: ACTIVE_COMPARATOR

Linagliptin/metformin FDC

Intervention Type: DRUG

Interventions

Linagliptin/metformin FDC

Intervention Type: DRUG

high-fat, high caloric meal

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests

2. Age 18 to 55 years (inclusive)

3. Body mass index (BMI) of 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 the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR, and ECG) which deviated from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

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

4. Surgery of the gastrointestinal tract (except appendectomy)

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

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

7. Chronic or relevant acute infections

8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)

9. Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration

10. Participated in another trial with an investigational drug within 2 months prior to administration or during the trial

11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)

12. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)

13. Drug abuse

14. Blood donation (more than 100 mL within 4 weeks prior to administration)

15. Any laboratory value outside the reference range that was of clinical relevance

16. Inability to comply with dietary regimen of trial site

For female subjects of childbearing potential only:

17. Positive pregnancy test, pregnancy, or had planned to become pregnant during the study or within 2 months after study completion

18. 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 were not surgically sterile were asked to use an additional barrier method (e.g. condom)

19. Lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1288.4

Identifier Type: -

Identifier Source: org_study_id