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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BIBV 308 SE solutionDrug: BIBV 308 SE capsule LDrug: BIBV 308 SE capsule S
- Registration Number
- NCT02223013
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIBV 308 SE solution BIBV 308 SE solution - BIBV 308 SE capsule L BIBV 308 SE capsule L - BIBV 308 SE capsule S BIBV 308 SE capsule S -
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma at steady state (AUCss) up to 84 hours Maximum plasma concentration at steady state (Cmax,ss) up to 84 hours Minimum plasma concentration at steady state (Cmin,ss) up to 84 hours
- Secondary Outcome Measures
Name Time Method Percent peak-to-trough fluctuation (%PTF) up to 84 hours Mean residence time in steady state (MRT,ss) up to 84 hours Time to maximum plasma concentration in steady state (tmax,ss) up to 84 hours Total plasma clearance (CL/f) up to 84 hours Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss) up to 84 hours Number of patients with adverse events up to 5 days after last drug administration Number of patients with clinically significant findings in vital signs up to 5 days after last drug administration pulse rate, blood pressure
Number of patients with clinically significant findings in laboratory tests up to 5 days after last drug administration Trough concentration of BIBV 308 SE before doses up to 84 hours