Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction

Inclusion Criteria:

1. Provide their signed study informed consent to participate.

2. Male or female ≥ 18 years of age at screening.

3. Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.

4. Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban,apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol,warfarin, etc.).

5. Subjects on VKAs can be enrolled if the subject's International Normalized Ratio (INR) at screening, but not more than 5 days before the dental extraction procedureis within the range of 2.0-3.5.

6. Subjects taking VKAs or DOACs can be enrolled if these are prescribed and usedaccording to the approved product label.

7. Accepting to not discontinue his/her anticoagulant medication on the day of theextraction.

8. Scheduled to undergo a single or multiple (≤ 5 teeth, single-rooted, double-rooted,or multi-rooted, maximum 3 multi-rooted teeth and 2 different extraction sites)tooth extraction. Subjects with a single extraction site may have up to a maximum of 5 adjacent teeth extracted at the site, and subjects with two extraction sites mayhave up to a maximum of 3 adjacent extracted teeth at one site and 2 adjacentextracted teeth at the other site.

9. Considered as reasonably healthy to follow the study procedures as documented by themedical history, physical examination, and vital sign assessments.

10. Subjects with a platelet count of 100,000-500,000 (inclusive) platelets permicroliter.

11. Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).

12. Willing to avoid alcohol consumption for the duration of the study.

13. Willing and able to adhere to the study assessment schedule and other protocolrequirements as evidenced by a written informed consent.

14. Negative pregnancy test in females of childbearing potential at Screening and Day 1visit.

15. Women must be post-menopausal (defined as no menses for 12 months without analternative medical cause), surgically sterile, or willing to use highly effectivemethod of birth control which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (refer to Table 4in protocol Section 8.2.11 for further information on acceptable and unacceptablebirth control methods). The Investigator is responsible for determining whether thesubject has adequate birth control for study participation.

Exclusion Criteria:

1. Any coagulation disorders requiring TXA.

2. Wisdom teeth extraction.

3. History of severe allergy or allergic reactions or hypersensitivity to the studydrug or any component of its formulations or related drugs or heparin

4. Subjects with type IV periodontitis (as per American Dental AssociationClassification) (see Appendix 1).

5. History of subarachnoid hemorrhage.

6. Active intravascular clotting (defined as a history of thrombosis within the past 3months).

7. Blood in the urine (macroscopic hematuria) at Screening.

8. Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73m² at Screening.

9. Any ongoing or planned dual anti-platelet treatment for the duration of subject'sparticipation in the study (any 2 of the following: aspirin, dipyridamole, or anythienopyridine, i.e., clopidogrel, prasugrel, ticlopidine, ticagrelor). However,subjects receiving a very low dose aspirin (≤ 160 mg) may be enrolled.

10. Any ongoing or planned oncological treatment for the duration of subject'sparticipation in the study.

11. Any immunocompromising condition.

12. Use of any recreational drugs or history of drug addiction.

13. Positive alcohol breath test at Screening and Day 1.

14. Participating in any other clinical study or has received treatment with anyinvestigational drug or device within 3 months prior to screening.

15. History of other disease, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or conditionthat contraindicates the use of the investigational drug, might affectinterpretation of the results of the study, or renders the subject at high risk fortreatment complications (including but not limited to diseases such as uncontrolleddiabetes, any haemato-oncological condition [e.g., leukemia], any congenitalhematological condition [e.g., hemophilia]).

16. Severe uncontrolled arterial hypertension, e.g., > 200 mmHg systolic or > 110 mmHgdiastolic blood pressure at two consecutive readings.

17. Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis Bsurface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.

18. Use of hormonal methods of birth control that increase the risk of thrombosis (e.g.,estrogen-containing contraceptives). Refer to Table 4 in protocol Section 8.2.11 forfurther information on acceptable and unacceptable birth control methods.

19. Women with intended pregnancy or breast-feeding.

20. Planned soft (other than extraction site) or hard oral tissue biopsy on the day ofthe surgery.

21. Subjects who are evaluated to have a negative risk-benefit ratio to participate inthis study (e.g., high risk of severe bleeding).