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Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan

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ClinicalTrials.gov Identifier: NCT03143166
Recruitment Status : Completed
First Posted : May 8, 2017
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 8, 2017
Results First Submitted Date  ICMJE July 24, 2018
Results First Posted Date  ICMJE January 16, 2019
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE May 22, 2017
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.
  • Maximum Concentration of Total Dabigatran in Plasma (Cmax). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This outcome is maximum measured concentration of the total dabigatran in plasma
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 3 days ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 3 days ]
Change History Complete list of historical versions of study NCT03143166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.
  • Maximum Concentration of Free Dabigatran in Plasma (Cmax). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This outcome is maximum measured concentration of the free dabigatran in plasma
  • Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity
  • Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). [ Time Frame: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose. ]
    This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • AUC0-tz (area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to the last quantifiable data point) [ Time Frame: Up to 3 days ]
  • Cmax (maximum measured concentration of free dabigatran in plasma) [ Time Frame: Up to 3 days ]
  • AUC0-∞ (area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 3 days ]
  • AUC0-∞ (area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 3 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan
Official Title  ICMJE Relative Bioavailability of Tablet Formulation of Dabigatran Etexilate With and Without Co-administration of Rabeprazole in Healthy Male Subjects (an Open-label, Single-dose, Two-period, Single-arm Study)
Brief Summary

The primary objective of this trial is to investigate the relative Bioavailability (BA) of tablet formulation of Dabigatran etexilate (DE) with and without co-administration of rabeprazole in healthy male subjects.

The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: Dabigatran Etexilate
    Tablet, film coated
    Other Name: MICARDIS, PRITOR, TELMISARTAN
  • Drug: Rabeprazol sodium
    Tablet
Study Arms  ICMJE Experimental: All participants
Dabigatran etexilate given without rabeprazole and then Dabigatran etexilate given without rabeprazole.
Interventions:
  • Drug: Dabigatran Etexilate
  • Drug: Rabeprazol sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2, 2017
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age ≥ 20 and ≤ 40 years at informed consent
  • Body mass index (BMI) of 18 ≥ and ≤ 25 kg/m2 at screening
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  • Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
  • Measurement of systolic blood pressure (BP) outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 45 to 90 bpm at screening
  • Any laboratory value outside the reference range before administration of DE that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Any relevant bleeding history considered by the investigator
  • Any history or evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Any history of hypochlorhydria or achlorhydria
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  • Planned surgeries within four weeks following the end-of trial examination
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
  • Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Inability to refrain from smoking at trial site
  • Alcohol abuse (consumption of more than 30 g per day: e.g., 750 ml of beer, 1.5 gous [equivalent to 270 mL] of Sake)
  • Drug abuse or positive drug screening
  • Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
  • Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
  • Inability to comply with dietary regimen of trial site
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03143166
Other Study ID Numbers  ICMJE 1160-0270
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP