Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers (NCT06689436) | Clinical Trial Compass
CompletedPhase 2
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
United States60 participantsStarted 2024-11-16
Plain-language summary
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is a male or female, 18-80 years of age, inclusive.
✓. Weight within the BMI of 18-32 kg/m2 inclusive and weighs at least 60 kg.
✓. Subject is willing and able to participate in all scheduled visits including follow up, treatment plan, laboratory tests and other study procedures according to clinical protocol.
✓. The subject is in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator.
✓. The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
✓. Subject doesn't have any relevant dietary restrictions, as determined by the Investigator, and is willing to consume a high-fat, high-calorie breakfast and other standard meals provided during the treatment periods of the study, and to comply with the fasting conditions required by the study design.
✓. The subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
✓. The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee.
Exclusion criteria
✕. The subject has a history of severe allergic or anaphylactic reactions.
✕
What they're measuring
1
Peak Plasma Concentration (Cmax) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions
Timeframe: From enrollment to the end of treatment at 10 weeks
2
Peak Plasma Concentration (Cmax) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Timeframe: From enrollment to the end of treatment at 10 weeks
3
Area under the plasma concentration curve from time zero to last sampling time (AUC0-t) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions
Timeframe: From enrollment to the end of treatment at 10 weeks
4
Area under the plasma concentration curve from time zero to last sampling time (AUC0-t) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Timeframe: From enrollment to the end of treatment at 10 weeks
5
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions
Timeframe: From enrollment to the end of treatment at 10 weeks
6
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Timeframe: From enrollment to the end of treatment at 10 weeks
. The subject has a known allergy or hypersensitivity to Apixaban, or history of any food or drug hypersensitivity or intolerance which in the opinion of the Investigator, would compromise the safety of the subject or the study.
✕. Current tongue piercing or other piercings in the mouth, including lips and cheeks which have studs/rings, etc. or where the piercing wound is not completely closed or any tongue or other oral deformities that may affect the absorption of the drug product.
✕. The subject has a medical history or current evidence of system disorders, organ dysfunction especially cardiovascular disorders (e.g., atrial fibrillation), renal or hepatic disorders which in the opinion of the Investigator, would compromise the safety of the subject or the study.
✕. Female subjects who are pregnant or lactating.
✕. The subject has a Family history of sudden cardiac death.
✕. The subject has a history of blood clots or bleeding disorders (e.g., bleeding diathesis \[tendency to bleed or bruise easily\]), stroke, or active pathological bleeding.
✕. The subject has a clinically significant history or are currently at risk for arterial or venous thromboembolic events (e.g., transient ischemic attack, cerebrovascular accident, myocardial infarction, retinal artery occlusion or retinal vein thrombosis, pulmonary embolism, deep vein thrombosis, antiphospholipid syndrome), as determined by the Investigator.