Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02223013
Start Date
April 1 1999
Last Update
August 22 2014
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