NCT Number: 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
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
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Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BIBV 308 SE capsule L
DrugBIBV 308 SE capsule S
DrugPrimary outcomes
-
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Time frame: up to 84 hours
-
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 84 hours
-
Minimum plasma concentration at steady state (Cmin,ss)
Time frame: up to 84 hours
Secondary outcomes
-
Percent peak-to-trough fluctuation (%PTF)
Time frame: up to 84 hours
-
Time to maximum plasma concentration in steady state (tmax,ss)
Time frame: up to 84 hours
-
Mean residence time in steady state (MRT,ss)
Time frame: up to 84 hours
-
Total plasma clearance (CL/f)
Time frame: up to 84 hours
-
Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)
Time frame: up to 84 hours
-
Number of patients with adverse events
Time frame: up to 5 days after last drug administration
-
Number of patients with clinically significant findings in vital signs
Time frame: up to 5 days after last drug administration
pulse rate, blood pressure
-
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 5 days after last drug administration
-
Trough concentration of BIBV 308 SE before doses
Time frame: up to 84 hours
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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)
Important dates
- Study start
- 1999
- Primary completion
- 1999
- First posted
- Aug 22, 2014
- Registry last updated
- Aug 22, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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