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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBV 308 SE solution

Drug: BIBV 308 SE capsule S

Drug: BIBV 308 SE capsule L

Study type

Interventional

Funder types

Industry

Identifiers

NCT02223013

528.204

Details and patient eligibility

About

Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.

Enrollment

9 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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