Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers

NCT ID: NCT02221401

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

Brief Summary

Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.

Conditions

Healthy

Study Design

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

Study Groups

Treatment A (FDC)

Group Type: EXPERIMENTAL

Linagliptin/Metformin FDC

Intervention Type: DRUG

Treatment B (single agents)

Group Type: ACTIVE_COMPARATOR

Linagliptin

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

Interventions

Linagliptin/Metformin FDC

Intervention Type: DRUG

Linagliptin

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

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 local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating 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) or 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. Participation 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 women and 30 g/day in men)

13. Drug abuse

14. Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)

15. Any laboratory value outside the reference range 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 planning 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 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

1288.1

Identifier Type: -

Identifier Source: org_study_id