Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS

NCT02180503 | Completed Phase 1

• 1 other identifier: 1218.8
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Up to 264 h after drug administration

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

  Up to 264 h after drug administration

Secondary Outcomes (11)

• 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 264 h after drug administration

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

  Up to 264 h after drug administration

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

  Up to 264 h after drug administration

• λz (terminal rate constant in plasma)

  Up to 264 h after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  Up to 264 h after drug administration

Study Arms (2)

BI 1356 BS - low dose

EXPERIMENTAL

Drug: BI 1356 BS PIB - low dose; Drug: BI 1356 BS tablet - low dose

BI 1356 BS - high dose

EXPERIMENTAL

Drug: BI 1356 BS PIB - high dose; Drug: BI 1356 BS tablet - high dose; Drug: BI 1356 BS tablet - high dose with food

Interventions

BI 1356 BS PIB - low dose DRUG

BI 1356 BS - low dose

BI 1356 BS tablet - low dose DRUG

BI 1356 BS - low dose

BI 1356 BS PIB - high dose DRUG

BI 1356 BS - high dose

BI 1356 BS tablet - high dose DRUG

BI 1356 BS - high dose

BI 1356 BS tablet - high dose with food DRUG

BI 1356 BS - high dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects 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
• No findings deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥21 and Age ≤65 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• 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:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin; Food

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: July 1, 2014
• First Posted: July 2, 2014
• Study Start: August 1, 2005
• Primary Completion: October 1, 2005
• Last Updated: July 8, 2014

Record last verified: 2014-07