Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBV 308 SE solution; Drug: BIBV 308 SE capsule 1; Drug: BIBV 308 SE capsule 2

• Registration Number: NCT02223000
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 1998-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIBV 308 SE solution	BIBV 308 SE solution	-
BIBV 308 SE capsule 1	BIBV 308 SE capsule 1	-
BIBV 308 SE capsule 2	BIBV 308 SE capsule 2	-

Primary Outcome Measures

Name	Time	Method
Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)	up to 84 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)	up to 84 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)	up to 84 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Mean residence time of the analyte in the body (MRTtot)	up to 84 hours after drug administration
Ratio of Cmax,ss/AUCss	up to 84 hours after drug administration
Apparent clearance of the analyte in plasma (CL/f)	up to 84 hours after drug administration
Trough concentrations of BIBV 308 SE before doses	up to day 4
Percent peak-trough fluctuation (%PTF)	up to 84 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)	up to 84 hours after drug administration