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OpenTrials
Completed

NCT Number: NCT02170766

Bioavailability of BIBR 953 ZW in Healthy Subjects

To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.

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Key information

Conditions

Age range

18 year–50 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

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with GCP and local legislation
  • Age ≥ 18 and ≤ 50 years
  • Broca ≥ - 20% and ≤ + 20%

Exclusion criteria

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
  • History of 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)
  • Commotio cerebri
  • Intake of drugs with a long half-life (>24 hours) within 1 month prior to administration
  • Use of any drugs which might influence the results of the trial within 10 days prior to administration or during 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 abuse (> 60 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 < 150000/µl

Treatment and study plan

BIBR 1048 low1

Drug

BIBR 1048 low2

Drug

BIBR 1048 medium

Drug

BIBR 1048 high

Drug

Pantoprazole

Drug

Primary outcomes

  1. AUC0-inf (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  2. AUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

Secondary outcomes

  1. Cmax (Maximum measured concentration) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  2. tmax (Time from dosing to the maximum concentration) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  3. MRTtot (Total mean residence time) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  4. CLtot/F (Total apparent clearance) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  5. Vz/F (Apparent volume of distribution) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  6. λz (terminal elimination rate constant) of BIBR 953 ZW

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  7. changes in activated partial thromboplastin time (aPTT)

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

  8. changes in international normalized ratio (INR)

    Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 25, 50 or 100 mg BIBR 1048 MS Film-coated Tablet With and Without Pre-treatment With Pantoprazole to Healthy Subjects. Four Groups, 2-way Crossover, Randomised, Open Trial.

Important dates

Study start
2000
Primary completion
2000
First posted
Jun 23, 2014
Registry last updated
Jun 23, 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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