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CompletedNCT02223013Updated Aug 22, 2014

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

A Phase 1 interventional study of BIBV 308 SE solution and BIBV 308 SE capsule L in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-22.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • DrugBIBV 308 SE solution
  • DrugBIBV 308 SE capsule L
  • DrugBIBV 308 SE capsule S
06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)

    Time frame: up to 84 hours

  2. Maximum plasma concentration at steady state (Cmax,ss)

    Time frame: up to 84 hours

  3. Minimum plasma concentration at steady state (Cmin,ss)

    Time frame: up to 84 hours

Secondary outcomes

  1. Percent peak-to-trough fluctuation (%PTF)

    Time frame: up to 84 hours

  2. Time to maximum plasma concentration in steady state (tmax,ss)

    Time frame: up to 84 hours

  3. Mean residence time in steady state (MRT,ss)

    Time frame: up to 84 hours

  4. Total plasma clearance (CL/f)

    Time frame: up to 84 hours

  5. Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)

    Time frame: up to 84 hours

  6. Number of patients with adverse events

    Time frame: up to 5 days after last drug administration

  7. Number of patients with clinically significant findings in vital signs

    pulse rate, blood pressure

    Time frame: up to 5 days after last drug administration

  8. Number of patients with clinically significant findings in laboratory tests

    Time frame: up to 5 days after last drug administration

  9. Trough concentration of BIBV 308 SE before doses

    Time frame: up to 84 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02223013
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 22, 2014
Start date
Apr 1999
Primary completion
May 1999
Last update
Aug 22, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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