NCT Number: NCT02170896
Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects
To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.
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Notify MeKey information
Conditions
Age range
18 year–55 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 (Good Clinical Practice) and local legislation
- Age >= 18 and <= 55 years
- Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m²
Exclusion criteria
- Any finding at the medical examination (including blood pressure, pulse rate and ECG (electrocardiogram)) deviation 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
- History of any bleeding disorder including prolonged or habitual bleeding
- History of other hematologic disease
- History of cerebral bleeding (e.g. after a car accident)
- History of commotio cerebri
- Intake of drug 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 (> 60g/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 Capsule B
DrugBIBR 1048 MS Capsule C
DrugBIBR 1048 MS Capsule D
DrugBIBR 1048 MS tartaric acid solution
DrugPantoprazole
DrugPrimary outcomes
-
Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals
Time frame: up to 3 days after each administration
-
Area under the concentration time course at steady state (AUCss)
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2
Secondary outcomes
-
Occurence of adverse events
Time frame: up to 40 days
-
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2
-
Time at which maximum plasma concentration occurs after dosing during steady state (tmax,ss)
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-way Crossover), Randomised, Open. For Each of the 5 Treatments, Investigation of 2 Conditions: With and Without Pantoprazole (Intraindividual, Open Comparison).
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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