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Completed

NCT Number: NCT02173730

BIBR 953 ZW in Healthy Elderly Subjects

To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

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

  • Healthy male and female elderly subjects as determined by results of screening
  • Signed written informed consent in accordance with GCP and local legislation
  • Age ≥ 65, no upper limit
  • BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion criteria

  • Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
  • History of relevant orthostatic hypotension, fainting spells and blackouts
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • History of
  • allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • any bleeding disorder including prolonged or habitual bleeding
  • other hematologic disease
  • cerebral bleeding (e.g. after a car accident)
  • cranio-cerebral trauma
  • Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
  • Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within 2 months prior to administration or during trial
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
  • Alcohol intake (>30 - 40 g/day)
  • Drug abuse
  • Blood donation within 1 month prior to administration or during the trial
  • Excessive physical activities within 5 days prior to administration or during the trial
  • Any laboratory value outside the clinically accepted reference range
  • History of any familial bleeding disorder
  • Thrombocytes < 140000/μl (male) or < 156000/μl (female)

Treatment and study plan

BIBR 1048 MS

Drug

BIBR 1048 MS capsule 150 mg

Pantoprazole

Drug

Pantoprazole tablet 40 mg

Primary outcomes

  1. AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)

    Time frame: Day 4 and 7

  2. Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

    Time frame: Day 4 and 7

  3. Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)

    Time frame: Day 4 and 7

  4. feτ,ss (percent of dose excreted in urine over one dosing interval at steady state)

    Time frame: Day 4 and 7

  5. AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz))

    Time frame: Day 4 and 7

  6. Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

    Time frame: Day 4 and 7

  7. tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

    Time frame: Day 4 and 7

  8. t½,ss (terminal half-life, calculated from the terminal elimination rate constant)

    Time frame: Day 4 and 7

Secondary outcomes

  1. CLR,ss (renal clearance at steady state following multiple dose administration)

    Time frame: Day 4 and 7

  2. MRTss (steady state mean residence time)

    Time frame: Day 4 and 7

  3. CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration)

    Time frame: Day 4 and 7

  4. Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)

    Time frame: Day 4 and 7

  5. Changes in activated partial thromboplastin time (aPTT)

    Time frame: Day 4 and 7

  6. Changes in ecarin clotting time (ECT)

    Time frame: Day 4 and 7

  7. Occurrence of Adverse Events

    Time frame: up to 10 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953) Administered as Capsule Twice Daily Over Seven Days With or Without Pantoprazole Co-treatment to Healthy Male and Female Elderly Subjects

Important dates

Study start
2002
Primary completion
2003
First posted
Jun 25, 2014
Registry last updated
Jun 25, 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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