Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how oral D-mannose tablets may affect the way the body processes a medication called dabigatran etexilate in healthy adult men. The trial aims to see if taking D-mannose for two weeks changes how dabigatran works in the body. Dabigatran is a medication that helps prevent blood clots, and understanding how D-mannose influences it could be important for future treatments.

To be eligible for this study, participants must be healthy adult men aged between 18 and 45 years, weigh at least 50 kg, and have a specific measure of kidney function. Those with certain medical conditions, such as severe digestive issues, a history of bleeding problems, or those who have recently used certain medications, may not qualify. Participants can expect to take the D-mannose tablets for the study duration and will be monitored closely throughout the trial. This study is currently recruiting participants, so if you meet the criteria and are interested, it might be a great opportunity to contribute to important medical research.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. With full capacity for civil conduct, the age of healthy male subjects is ≥18 years old and ≤45 years old
• • 2. Male weight ≥50 kg; body mass index (BMI) within the range of 19.0\~27.0 (including upper and lower limits)
• • 3. Creatinine clearance rate (CRCL: calculated by Cock croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min
• Exclusion Criteria:
• • 1. History of fainting of needles and blood.
• • 2. Diseases affecting intestinal P-glycoprotein: severe diarrhea (excretion more than 3 times a day with watery stool characteristics), Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulitis, difficult Identify Clostridium infection (recurrent) or Helicobacter pylori infection.
• • 3. Diabetes mellitus; Impaired fasting glucose (IFG); Impaired glucose tolerance (IGT); Oral hypoglycemic agents (including the use of hypoglycemic agents for weight loss purposes).
• • 4. Diseases or conditions with significant risk of major bleeding, such as current or recent peptic ulcer, malignant neoplasms with high bleeding risk, recent brain or spinal cord injury, recent brain, spinal cord, or eye surgery, recent intracranial hemorrhage, known or suspected Esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracranial vascular abnormalities.
• • 5. Clinically significant active bleeding.
• • 6. Taking anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (LMWH) and heparin derivatives (fondaparinux sodium), vitamin K antagonists, rivaroxaban or other direct thrombin inhibitors (recombinant hirudin, bivalirudin); thrombolytic drugs, or current use of antiplatelet aggregation drugs such as GPⅡb/Ⅲa receptor antagonists, ticlopidine, prasugrel, dextran, sulfinpyrazone, aspirin, etc.
• • 7. Use of drugs that may affect the activity of intestinal p-glycoprotein within 1 week before the trial: (1) potent p-glycoprotein inhibitors: amiodarone, verapamil, diltiazem, quinidine, dronedarone, tacrolimus, cyclosporine, protease inhibitors(indinavir, nelfinavir, saquinavir, lopinavir), macrolide antibiotics (erythromycin, clarithromycin, telithromycin, chloramphenicol), azole antifungal drugs (ketoconazole, itraconazole, Posaconazole, voriconazole, fluconazole, miconazole), nefazodone, cobicistat, cimetidine, ciprofloxacin, cyclosporin, fluvoxamine, imatinib, St. John's Wort, ranolazine; (2) Potent P-glycoprotein inducers: rifampicin, carbamazepine, phenytoin, phenobarbital, antiandrogens(enzalutamide, apalutamide), phenobarbital, dexamethasone.
• • 8. Those who have a history of smoking and drinking in the past and who do not agree with the prohibition of smoking and drinking during the trial period: smokers (the average daily cigarettes smoked more than 5 cigarettes within one month before the test); alcoholism: (the average daily drinking within one month before the test≥100mL high-quality liquor/200mL wine / 600mL beer).
• • 9. History of gastrointestinal surgery such as gallbladder or appendectomy, bariatric surgery, etc. within the past 5 years.
• • 10. Positive virological test (human immunodeficiency virus antibody (HIV-Ab), syphilis serological test, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)) within 6 months before screening.
• • 11. Those who have participated in clinical trials of any dug or medial device within 6 months before screening (in the case of drug clinical trials those who participated in the previous clinical trial before screening have more than 5 half-lives).
• • 12. Subjects who are considered by the investigator to have any factors that are not suitable for participating in this trial.