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Clinical Trials/NCT02170974
NCT02170974CompletedPhase 1

Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as HPMC Polymorph II Capsule Relative to 150 mg HPMC Polymorph I Capsule in Healthy Subjects. A Two-way Crossover, Randomised, Open Trial

Boehringer Ingelheim0 sites28 target enrollmentStarted: July 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
28
Primary Endpoint
AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph I in HPMC capsules

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy female and male subjects as determined by results of screening
  • •Signed written informed consent in accordance with GCP and local legislation
  • •Age ≥ 18 and ≤ 55 years
  • •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
  • •History of or current 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)
  • •commotio cerebri
  • •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 abuse (> 60 g/day)
  • •Drug abuse
  • •Blood donation of more than 400 ml within 4 weeks 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 reference range of clinical relevance
  • •History of any familial bleeding disorder
  • •Platelets < 150000/μl

Arms & Interventions

BIBR 1048 MS polymorph II

Experimental

Intervention: BIBR 1048 MS polymorph II (Drug)

BIBR 1048 MS polymorph I

Active Comparator

Intervention: BIBR 1048 MS polymorph I (Drug)

Outcomes

Primary Outcomes

AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity)

Time Frame: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration

AUC0-tz

Time Frame: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration

Cmax (maximum measured plasma concentration of BIBR 953 ZW)

Time Frame: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration

Secondary Outcomes

  • tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses )(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
  • t1/2 (half life)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
  • MRTpo (mean time of residence of drug molecules in the body)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
  • CL/F (apparent clearance after oral administration)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
  • Vz/F (apparent volume of distribution)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
  • Changes in ECG(up to 31 days)
  • Changes in systolic and diastolic blood pressure(up to 31 days)
  • Occurrence of adverse events(up to 31 days)
  • Assessment of tolerability by investigator on a four-point scale(up to 31 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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