Clinical trial NCT02223013: Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects
Official title: Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of 50 mg BIBV 308 SE Each, Versus a Solution of 50 mg BIBV 308 SE Administered Orally Twice a Day for 3.5 Days to Healthy Subjects (Cross-over, Open, Randomized)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.


Eligibility criteria: Inclusion Criteria:

* Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 55 years
* Broca \>= -20% and \<= +20 %

Exclusion Criteria:

* Poor individual absorption kinetics of BIBV 308 SE in previous studies
* Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or acute relevant infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Hypersensitivity to BIBV 308 SE and any of the excipients
* Intake of drugs with a long half-life (\> 24 hours) \<= 1 month prior to administration or during the trial
* Use of any drugs which might influence the results of the trial \<= 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug \<= 2 months days prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking during the period of the study
* Known alcohol (\> 60 g/day) or drug abuse
* Blood donation (\<= 1 month prior to administration)
* Excessive physical activities (\<= 5 days prior to administration)
* Any laboratory value outside the normal range of clinical relevance
* History of haemorrhagic diathesis
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
timeFrame: up to 84 hours
measure: Maximum plasma concentration at steady state (Cmax,ss)
timeFrame: up to 84 hours
measure: Minimum plasma concentration at steady state (Cmin,ss)
timeFrame: up to 84 hours
Secondary outcomes:
measure: Percent peak-to-trough fluctuation (%PTF)
timeFrame: up to 84 hours
measure: Time to maximum plasma concentration in steady state (tmax,ss)
timeFrame: up to 84 hours
measure: Mean residence time in steady state (MRT,ss)
timeFrame: up to 84 hours
measure: Total plasma clearance (CL/f)
timeFrame: up to 84 hours
measure: Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)
timeFrame: up to 84 hours
measure: Number of patients with adverse events
timeFrame: up to 5 days after last drug administration
measure: Number of patients with clinically significant findings in vital signs
timeFrame: up to 5 days after last drug administration
measure: Number of patients with clinically significant findings in laboratory tests
timeFrame: up to 5 days after last drug administration
measure: Trough concentration of BIBV 308 SE before doses
timeFrame: up to 84 hours
Other outcomes:
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References: