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Trial record 96 of 333 for:    DABIGATRAN

Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02170623
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after administration of 50 mg of BIBR 1048 bid over three days each administered as two experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBR 1048 MS Capsule I Drug: BIBR 1048 MS Capsule K Drug: Pantoprazole Drug: BIBR 1048 MS drinking solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 2 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days in Healthy Subjects. Intraindividual Comparison (3-way Crossover) With and Without Pantoprazole, Randomised, Open.
Study Start Date : February 2002
Actual Primary Completion Date : April 2002


Arm Intervention/treatment
Experimental: Period 1: BIBR 1048 MS with Pantoprazole

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) with 40 mg Pantoprazole (bid). Randomised sequence.

  1. BIBR 1048 MS Capsule I with pantoprazole (bid for 3 days);
  2. BIBR 1048 MS Capsule K with pantoprazole (bid for 3 days);
  3. BIBR 1048 MS Drinking solution with Pantoprazole (bid for 3 days)
Drug: BIBR 1048 MS Capsule I
25 mg BIBR 1048 MS

Drug: BIBR 1048 MS Capsule K
50 mg BIBR 1048 MS

Drug: Pantoprazole
40 mg pantoprazole

Drug: BIBR 1048 MS drinking solution
50 mg BIBR 1048 MS powder plus solution

Experimental: Period 2: BIBR 1048 MS

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) without Pantoprazole. Fixed sequence.

  1. BIBR 1048 MS Capsule K (bid for 3 days);
  2. BIBR 1048 MS Drinking solution (bid for 3 days)
Drug: BIBR 1048 MS Capsule K
50 mg BIBR 1048 MS

Drug: BIBR 1048 MS drinking solution
50 mg BIBR 1048 MS powder plus solution




Primary Outcome Measures :
  1. Total amount of BIBR 953 ZW excreted into urine during one dosing interval (Ae0-12) [ Time Frame: Day 1 to day 10 ]
  2. AUCss (Area under the plasma concentration-time curve at steady state) of BIBR 953 ZW [ Time Frame: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period ]

Secondary Outcome Measures :
  1. Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW [ Time Frame: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period ]
  2. tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW [ Time Frame: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ≤ 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 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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02170623     History of Changes
Other Study ID Numbers: 1160.33
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dabigatran
Pantoprazole
Pharmaceutical Solutions
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants