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OpenTrials
Completed

NCT Number: NCT02223013

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIBV 308 SE solution

Drug

BIBV 308 SE capsule L

Drug

BIBV 308 SE capsule S

Drug

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

    Time frame: up to 5 days after last drug administration

    pulse rate, blood pressure

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
1999
Primary completion
1999
First posted
Aug 22, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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