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OpenTrials
Completed

NCT Number: NCT02170792

Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.

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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 <0 + 20%

Exclusion criteria

  • any finding of the medical examination (including blood pressure, pulse rate and ECG)
  • history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
  • history of orthostatic hypotension, fainting spells and blackouts
  • diseases of 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 administration
  • participation in another trial with an investigational drug within 2 month 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 MS

Drug

Low, medium or high dose

Ranitidine

Drug

150mg

Other names: Zantic ®

Primary outcomes

  1. Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)

    Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

  2. Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)

    Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

Secondary outcomes

  1. Maximum concentration of drug in plasma ( Cmax )

    Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

  2. Time from dosing to the maximum concentration of the analyte in plasma (tmax)

    Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

  3. Changes from baseline in Pulse rate

    Time frame: baseline up to 36 h after last administration

  4. Changes from baseline in blood pressure (systolic and diastolic)

    Time frame: baseline up to 36 h after last administration

  5. Changes from baseline in ECG

    Time frame: baseline up to 36 h after last administration

  6. Changes from baseline in routine laboratory

    Time frame: baseline up to 36 h after last administration

  7. Number of participants with adverse events

    Time frame: up to 36 h after last administration

  8. Changes in international normalized ratio (INR )

    Time frame: before and 2 hours after treatment

  9. Changes in activated prothrombin time (aPTT)

    Time frame: before and 2 hours after treatment

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, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.

Important dates

Study start
2001
Primary completion
2001
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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