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

NCT02223013 | Completed Phase 1

• 1 other identifier: 528.204
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (3)

BIBV 308 SE solution

ACTIVE COMPARATOR

Drug: BIBV 308 SE solution

BIBV 308 SE capsule L

EXPERIMENTAL

Drug: BIBV 308 SE capsule L

BIBV 308 SE capsule S

EXPERIMENTAL

Drug: BIBV 308 SE capsule S

Interventions

BIBV 308 SE solution DRUG

BIBV 308 SE solution

BIBV 308 SE capsule L DRUG

BIBV 308 SE capsule L

BIBV 308 SE capsule S DRUG

BIBV 308 SE capsule S

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: April 1, 1999
• Primary Completion: May 1, 1999
• Last Updated: August 22, 2014

Record last verified: 2014-08