Bioavailability of BIBR 953 ZW After BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as Hydroxypropyl Methylcellulose (HPMC) Polymorph II Capsule Relative to HPMC Polymorph I Capsule in Healthy Subjects.

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBR 1048 MS polymorph II

Drug: BIBR 1048 MS polymorph I

Study type

Interventional

Funder types

Industry

Identifiers

NCT02170974

1160.52

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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