Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers

NCT ID: NCT01216397

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30

Brief Summary

The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).

Conditions

Healthy

Study Design

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

Study Groups

Linagliptin/Metformin (standard batch)

Fixed dose combination tablet

Group Type: EXPERIMENTAL

Linagliptin/Metformin (standard batch)

Intervention Type: DRUG

Fixed dose combination tablet

Linagliptin/Metformin (side batch)

Fixed dose combination tablet

Group Type: EXPERIMENTAL

Linagliptin/Metformin (side batch)

Intervention Type: DRUG

Fixed dose combination tablet

Interventions

Linagliptin/Metformin (standard batch)

Fixed dose combination tablet

Intervention Type: DRUG

Linagliptin/Metformin (side batch)

Fixed dose combination tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

2. Age 21 to 50 years (incl.)

3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

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) 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 one 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 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 four weeks prior to day 1 of visit 2)

15. Any laboratory value outside the reference range that is 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 1 month before study or within 2 months after study completion

18. No adequate contraception 1 month before study and until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal IUD (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 sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom).

19. Lactation

• Minimum Eligible Age: 21 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

1288.6.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Countries

Germany

Other Identifiers

2010-019291-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1288.6

Identifier Type: -

Identifier Source: org_study_id