NCT Number: NCT02170922
Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food
Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food
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Notify MeKey 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 or 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 MS solution
DrugPrimary outcomes
-
Area under the curve (AUC) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Maximum plasma concentration (Cmax) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Time from dosing to the maximum concentration (tmax) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
Secondary outcomes
-
Change in activated partial thromboplastin time (aPTT)
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Change in international normalized ratio (INR)
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Terminal half-life (t1/2 ) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Total mean residence time (MRTtot) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Total clearance (CL/f) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
-
Volume of distribution (Vz/F) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 48 hours after administration of study drug
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Relative Bioavailability of 200 mg Film Coated Tablets of BIBR 1048 MS With or Without Food Compared to 200 mg Solution of BIBR 1048 MS Given as Single Oral Administrations to Healthy Subjects. A 3-way Crossover, Open, Partly Randomized Study.
Important dates
- Study start
- 1999
- Primary completion
- 1999
- 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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