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COMPLETEDPHASE1

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

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)

NCT03143166•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 40 years

Sex

MALE

Healthy Volunteers

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
+14 more criteria

Locations (1)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, Japan

Key Dates

Start Date

May 22, 2017

Primary Completion Date

July 27, 2017

Completion Date

August 2, 2017

Last Updated

January 16, 2019

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Dabigatran Etexilate

DRUG

Rabeprazol sodium

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

View study

RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

NCT07221227

Non-alcoholic Fatty Liver Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities