Clinical trial NCT02223000: Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
Official title: Relative Bioavailability and Tolerability of Various Experimental Formulations of 50 mg BIBV 308 SE Administered Orally Twice a Day Over 3.5 Days to Healthy Subjects (Intraindividual Comparison, Open, Partially Randomised).
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 of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability


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 disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* 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 on study days
* Known alcohol or drug abuse
* Blood donation \<= 1 month prior to administration
* Excessive physical activities \<= 5 days prior to administration
* History of hemorrhagic diathesis
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
* Any laboratory value outside the reference range of clinical relevance

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
timeFrame: up to 84 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
timeFrame: up to 84 hours after drug administration
measure: Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
timeFrame: up to 84 hours after drug administration
Secondary outcomes:
measure: Percent peak-trough fluctuation (%PTF)
timeFrame: up to 84 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
timeFrame: up to 84 hours after drug administration
measure: Mean residence time of the analyte in the body (MRTtot)
timeFrame: up to 84 hours after drug administration
measure: Apparent clearance of the analyte in plasma (CL/f)
timeFrame: up to 84 hours after drug administration
measure: Ratio of Cmax,ss/AUCss
timeFrame: up to 84 hours after drug administration
measure: Trough concentrations of BIBV 308 SE before doses
timeFrame: up to day 4
Other outcomes:
Locations:
Study officials:
References: