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

NCT02223026 | Completed Phase 1

• 1 other identifier: 1288.4
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)

  up to 72 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 h extrapolated to infinity)

  up to 72 hours after drug administration

Secondary Outcomes (14)

• AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 h extrapolated to infinity)

  up to 72 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 72 hours after drug administration

• AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

  up to 72 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours after drug administration

• λz (terminal elimination rate constant in plasma)

  up to 72 hours after drug administration

Study Arms (2)

Linagliptin/metformin fed

EXPERIMENTAL

Drug: Linagliptin/metformin FDC; Other: high-fat, high caloric meal

Linagliptin/metformin fasted

ACTIVE COMPARATOR

Drug: Linagliptin/metformin FDC

Interventions

Linagliptin/metformin FDC DRUG

Linagliptin/metformin fasted; Linagliptin/metformin fed

high-fat, high caloric meal OTHER

Linagliptin/metformin fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age 18 to 55 years (inclusive)
• Body mass index (BMI) of 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

You may not qualify if:

• Any finding of the medical examination (including BP, PR, and ECG) which deviated 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), 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
• Participated 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 females and 30 g/day in males)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks prior to administration)
• Any laboratory value outside the reference range that was of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: August 22, 2014

Record last verified: 2014-08