Bioavailability of BI 1356 BS and Metformin After Co-administration Compared to the Bioavailability of BI 1356 BS Alone and Metformin Alone in Healthy Male Volunteers

NCT02183506 | Completed Phase 1

• 1 other identifier: 1218.4
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI 1356 BS and metformin given alone

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve (AUC) of the analytes in plasma at different time points

  up to 240 hours after start of treatment

• Maximum concentration (Cmax) of the analytes in plasma at different time points

  up to 240 hours after start of treatment

Secondary Outcomes (13)

• Time from last dosing to maximum concentration of the analytes in plasma at steady state (tmax,ss)

  up to 240 hours after start of treatment

• Minimum concentration of the analytes in plasma at steady state (Cmin,ss) over a uniform dosing interval τ

  up to 240 hours after start of treatment

• Terminal rate constant of the analytes in plasma at steady state (λz,ss )

  up to 240 hours after start of treatment

• Terminal half-life of the analytes in plasma at steady state (t1/2,ss )

  up to 240 hours after start of treatment

• Mean residence time of the analytes in the body at steady state after oral administration (MRTpo,ss)

  up to 240 hours after start of treatment

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Drug: Metformin

BI 1356 BS and metformin

EXPERIMENTAL

Daily administration of BI 1356 BS alone (day 1 to day 6) followed by the combined treatment of BI 1356 BS with metformin (day 7 to day 9)

Drug: Metformin; Drug: BI 1356 BS

Interventions

Metformin DRUG

BI 1356 BS and metformin; Metformin

BI 1356 BS DRUG

BI 1356 BS and metformin

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males 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 finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 21 and Age ≤ 50 years
• BMI (Body Mass Index) ≥ 18.5 and ≤ 29.9 kg/m2
• Ability to give 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 the 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 by the investigator
• Intake of drugs with a long half-life (\>24 hours) within one month or less than 10 half-lives of the respective drug prior to administration or during the conduct of this trial (review with clinical monitor if there is a question)
• Use of drugs which might reasonably influence the results of the trial (based on knowledge at the time of protocol preparation) within 10 days prior to administration or during the conduct of this trial
• Participation in another trial with an investigational drug within two months prior to administration or during the conduct of this trial
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking during the conduct of this trial
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the conduct of this trial)
• Excessive physical activities (within one week prior to administration or during the conduct of this trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Metformin; Linagliptin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 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: July 4, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2005
• Primary Completion: December 1, 2005
• Last Updated: July 8, 2014

Record last verified: 2014-07