NCT Number: NCT02223000
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
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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 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
Treatment and study plan
BIBV 308 SE capsule 1
DrugBIBV 308 SE capsule 2
DrugPrimary outcomes
-
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Time frame: up to 84 hours after drug administration
-
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Time frame: up to 84 hours after drug administration
-
Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
Time frame: up to 84 hours after drug administration
Secondary outcomes
-
Percent peak-trough fluctuation (%PTF)
Time frame: up to 84 hours after drug administration
-
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: up to 84 hours after drug administration
-
Mean residence time of the analyte in the body (MRTtot)
Time frame: up to 84 hours after drug administration
-
Apparent clearance of the analyte in plasma (CL/f)
Time frame: up to 84 hours after drug administration
-
Ratio of Cmax,ss/AUCss
Time frame: up to 84 hours after drug administration
-
Trough concentrations of BIBV 308 SE before doses
Time frame: up to day 4
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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).
Important dates
- Study start
- 1998
- Primary completion
- 1998
- 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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