A study on the impact of rabeprazole-induced elevated stomach ph on apo-dabigatran exposure in healthy volunteers

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
Inclusion Criteria: 1. 20 to 40 years old 2. Body mass index 18‐25 kg/m2 3. Male. Those able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information sheet. Exclusion Criteria: 1. Any documented history of heart, lung, liver, kidney, gastrointestinal, genitourinary, musculoskeletal or endocrine disorders or other systemic illness not specifically listed. 2. Regular use of any medications or herbal supplements/remedies (e.g. St. John's wort). 3. Laboratory values outside of reference range that may compromise safety or validity of the trial. 4. Smoking or alcohol consumption such that the investigators feel that they will not be able to comply with the trial protocol. 5. Measures at screening outside of the reference ranges for systolic and diastolic blood pressure (>140/90) and pulse rate (>90/min). 6. Patients who are not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (includes any condition that, in the investigator's opinion, makes the patient an unreliable trial participant). 7. Previous enrolment in this trial. 8. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s) Atrial Fibrillation;Venous Thromboembolism
Epistemonikos ID: 4880a9d5b43b783982b72a326334178c1c66e215
First added on: May 06, 2024