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

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIBV 308 SE solution; Drug: BIBV 308 SE capsule L; Drug: BIBV 308 SE capsule S

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BIBV 308 SE solution	Drug: BIBV 308 SE solution
Experimental: BIBV 308 SE capsule L	Drug: BIBV 308 SE capsule L
Experimental: BIBV 308 SE capsule S	Drug: BIBV 308 SE capsule S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)	up to 84 hours
Maximum plasma concentration at steady state (Cmax,ss)	up to 84 hours
Minimum plasma concentration at steady state (Cmin,ss)	up to 84 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent peak-to-trough fluctuation (%PTF)		up to 84 hours
Time to maximum plasma concentration in steady state (tmax,ss)		up to 84 hours
Mean residence time in steady state (MRT,ss)		up to 84 hours
Total plasma clearance (CL/f)		up to 84 hours
Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)		up to 84 hours
Number of patients with adverse events		up to 5 days after last drug administration
Number of patients with clinically significant findings in vital signs	pulse rate, blood pressure	up to 5 days after last drug administration
Number of patients with clinically significant findings in laboratory tests		up to 5 days after last drug administration
Trough concentration of BIBV 308 SE before doses		up to 84 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): May 1, 1999

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 528.204