Bioavailability of Combination Tablet BI 1356/Metformin Compared With Single BI 1356 and Metformin Administered Together to Healthy Male and Female Subjects

NCT02173639 | Completed Phase 1

• 1 other identifier: 1218.47
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to assess the relative bioavailability of a pilot scale linagliptin 2.5 mg / metformin 1000 mg fixed dose combination (FDC) tablet in comparison with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUC0-72 h (area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h)

  up to 72 hours after administration

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

  up to 168 hours after administration

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

  up to 168 h after administration

Secondary Outcomes (11)

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

  up to 168 hours after administration

• λz (terminal elimination rate constant of the analyte in plasma)

  up to 168 hours after administration

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

  up to 168 hours after administration

• MRTpo (mean residence time of the analyte in the body after po administration)

  up to 168 hours after administration

• CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

  up to 168 hours after administration

Study Arms (2)

BI 1356/metformin

EXPERIMENTAL

Drug: BI 1356/metformin

BI 1356 + Metformin

EXPERIMENTAL

Drug: BI 1356; Drug: Metformin

Interventions

BI 1356/metformin DRUG

fixed dose combination tablet

BI 1356/metformin

BI 1356 DRUG

BI 1356 + Metformin

Metformin DRUG

BI 1356 + Metformin

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 based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests
• Age ≥18 and ≤ 55 years
• BMI ≥18.5 and ≤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 and the local legislation

You may not qualify if:

• Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg
• 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) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out
• Participation in another trial with an investigational drug within two months prior to first study drug administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on pharmacokinetic study days
• Alcohol abuse (average consumption of more than 20 g/day in females and more than 30 g/day in males)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to the start of study)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin; Metformin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

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: June 24, 2014
• First Posted: June 25, 2014
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07