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

NCT ID: NCT02223013

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBV 308 SE solution

Group Type: ACTIVE_COMPARATOR

BIBV 308 SE solution

Intervention Type: DRUG

BIBV 308 SE capsule L

Group Type: EXPERIMENTAL

BIBV 308 SE capsule L

Intervention Type: DRUG

BIBV 308 SE capsule S

Group Type: EXPERIMENTAL

BIBV 308 SE capsule S

Intervention Type: DRUG

Interventions

BIBV 308 SE solution

Intervention Type: DRUG

BIBV 308 SE capsule L

Intervention Type: DRUG

BIBV 308 SE capsule S

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

528.204

Identifier Type: -

Identifier Source: org_study_id