Random AllocationPhase 2NCT06689436
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
A Phase 2 study testing 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed) and 5 mg Apixaban Oral Tablet (US RS/RLD) in people with Random Allocation and Intermittent Fasting, run by TAHO Pharmaceuticals Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Random Allocation, Intermittent Fasting, Enteral Feeding
- What is being tested?
- 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed) and 5 mg Apixaban Oral Tablet (US RS/RLD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2024to 1 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- 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.
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- 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.
- If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL.
- Male subjects who are not surgically sterile must agree to use appropriate contraceptive measures and agree to not impregnate a female partner(s) and not to donate sperm throughout the entire study, including the washout periods, and for 30 days after the last study drug administration. Examples of acceptable methods of contraception include a double-barrier method of contraception (e.g., condom with spermicide). Other forms of contraception may be acceptable, at the discretion of the Investigator.
Who cannot join
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- The subject has a history of severe allergic or anaphylactic reactions.
- 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.
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- 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.
- The subject has had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (e.g., mild rhinorrhea), untreated oral/dental abnormalities (e.g., untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin.
- The subject has a positive test for human immunodeficiency virus (HIV) types 1 or 2, Hepatitis B surface antigen or Hepatitis C antibody (HCV) at screening.
- Subject has any active infection requiring systemic therapy at the time of screening, which is considered clinically significant per the Principial Investigator.
- The investigator determined the subject has a history of or ongoing chronic or recurrent infectious disease (e.g., infected indwelling prosthesis, osteomyelitis, chronic sinusitis)
- Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
- History of excessive alcohol consumption (on average more than 14 units of alcohol/week; 1 unit = 12 oz. beer, 6 oz. wine, 1 shot [1.5 oz.] of liquor) during the past 12 months.
- The subject has taken any medications (including herbal remedies) known to significantly induce or inhibit drug metabolizing enzymes (especially inhibitors and inducers of CYP3A4 and P-gp such as ketoconazole, itraconazole, ritonavir, clarithromycin, rifampin, phenytoin, carbamazepine, St. John's Wort, etc.) within 30 days before initial dosing and other medications deemed acceptable by the Principal Investigator.
- Clinically significant history or presence of gastrointestinal disease (e.g., bleeding, perforation, or fistulas) or malabsorption, as determined by the Investigator.
- The subject has participated in another clinical study of a new investigational drug or has received an investigational drug within 28 days or 5 half-lives (if available) before study drug administration, whichever is longer.
- Anticipating undergoing surgery or medical/dental procedure, receiving neuraxial anesthesia (spinal/epidural anesthesia), or undergoing spinal puncture during the study or within 7 days after study completion.
- Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
- Subject has difficulty swallowing, as determined by the investigator.
- Subject has a prosthetic heart valve.
- Subject has abnormal prothrombin time (PT) and activated partial thromboplastin time (aPTT).
- The subject has serum creatinine ≥1.5 mg/dL
- eGFR<90 mL/min/1.73 m2; obtained from the clinical laboratory tests performed at screening.
- Use of drugs affecting hemostasis such as aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and nonsteroidal anti-inflammatory drugs (NSAIDs) within 14 days before initial dosing.
- Positive test results for drugs of abuse or cotinine at screening
- The subject is unable to participate in, or successfully complete, the study, in the opinion of the investigator, because the subject is any of the following:
- Mentally or legally incapacitated, or unable to give consent for any reason
- Unlikely to cooperate or comply with the clinical study protocol or is unsuitable for any other reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services, USA
Las Vegas, Nevada, 89121
About this study
Official title: A Pivotal, Randomized, Single-dose, Open-label, Four-Way Crossover, BE Study of TAH3311 (Apixaban ODF) Under Fasted and Fed Conditions vs. ELIQUIS® Oral Tablet Under Fasted Condition in Healthy Volunteers
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.
Read the detailed description
Eligible subjects will be enrolled in the study across four sequences (anticipate 15 subjects per sequence). This study will have three phases: Screening Phase, Treatment Phase, and Follow-Up Phase. Subjects will be randomized 1:1:1:1 to receive TAH3311 ODF 5 mg under fasted (T1) and fed conditions (T2) and ELIQUIS® 5 mg (US RS/RLD [R1] and EU product [R2]) under fasted condition via one of the four sequences with serial PK sampling from 90 minutes pre-dose to 48 hours post-dose. The duration of each treatment period is 4 days, with a 7±2 days washout in between of the treatment administration. The follow-up period will be 7±3 days after the last treatment dosing.
- Conditions
- Random Allocation, Intermittent Fasting, Enteral Feeding
- Being tested
- 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed), 5 mg Apixaban Oral Tablet (US RS/RLD), 5 mg Apixaban Oral Tablet (EU product)
- Keywords
- Crossover Design, Therapeutic Equivalency
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg Apixaban Oral Dissolving Film (fasting)Drug
Also called TAH3311 ODF
Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally after at least 10 hours overnight fast
5 mg Apixaban Oral Dissolving Film (fed)Drug
Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that is preceded by at least 10 hours overnight fast
5 mg Apixaban Oral Tablet (US RS/RLD)Drug
Also called ELIQUIS® (US RS/RLD)
Single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) will be administered orally after at least 10 hours overnight fast
5 mg Apixaban Oral Tablet (EU product)Drug
Single dose of 5 mg Apixaban Oral Tablet (EU product) will be administered orally after at least 10 hours overnight fast
| Study group | Role | What they receive |
|---|---|---|
| 5 mg Apixaban Oral Dissolving Film (fasting) | Experimental | Treatment T1: Subject will receive a single dose of 5 mg Apixaban Oral Dissolving Film under fasting condition Receives: Drug: 5 mg Apixaban Oral Dissolving Film (fasting) |
| 5 mg Apixaban Oral Dissolving Film (fed) | Experimental | Treatment T2: Subject will receive a single dose of 5 mg Apixaban Oral Dissolving Film under fed condition. Receives: Drug: 5 mg Apixaban Oral Dissolving Film (fed) |
| 5 mg Apixaban Oral Tablet (US RS/RLD) | Active comparator | Treatment R1: Subject will receive a single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) under fasting condition. Receives: Drug: 5 mg Apixaban Oral Tablet (US RS/RLD) |
| 5 mg Apixaban Oral Tablet (EU product) | Active comparator | Treatment R2: Subject will receive a single dose of 5 mg Apixaban Oral Tablet (EU product)) under fasting condition. Receives: Drug: 5 mg Apixaban Oral Tablet (EU product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions
Measured: From enrollment to the end of treatment at 10 weeks
Peak Plasma Concentration (Cmax) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Measured: From enrollment to the end of treatment at 10 weeks
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
Measured: From enrollment to the end of treatment at 10 weeks
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
Measured: From enrollment to the end of treatment at 10 weeks
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
Measured: From enrollment to the end of treatment at 10 weeks
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Measured: From enrollment to the end of treatment at 10 weeks
Secondary outcomes (3)
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
Measured: From enrollment to the end of treatment at 10 weeks
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for ELIQUIS® 5mg Oral Tablets (for the EU product) under fasted conditions
Measured: From enrollment to the end of treatment at 10 weeks
Obtaining specific pharmacokinetic parameters for Apixaban following single dose administration under fasted and fed conditions:
The specific PK parameters to be calculated include at least:
- Apparent terminal elimination half-life (t1/2)
- Time to maximum observed plasma drug concentration (Tmax)
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start16 Nov 2024
- Primary completion15 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Random AllocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TAHO Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiffany A Bradley, MD, Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689436
- Sponsor's protocol ID
- TAH3311-CP-2301
- Status last verified
- Apr 2025
- First submitted
- 11 Nov 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Randomized, Single-dose, Open-label, Four-Way Crossover, BE Study of TAH3311 (Apixaban ODF) Under Fasted and Fed Conditions vs. ELIQUIS® Oral Tablet Under Fasted Condition in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06689436
- Acronym / sponsor ID
- TAH3311-CP-2301
- Conditions
- Random Allocation, Intermittent Fasting, Enteral Feeding
- Keywords
- Crossover Design, Therapeutic Equivalency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TAHO Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects will be enrolled in the study across four sequences (anticipate 15 subjects per sequence). This study will have three phases: Screening Phase, Treatment Phase, and Follow-Up Phase. Subjects will be randomized 1:1:1:1 to receive TAH3311 ODF 5 mg under fasted (T1) and fed conditions (T2) and ELIQUIS® 5 mg (US RS/RLD [R1] and EU product [R2]) under fasted condition via one of the four sequences with serial PK sampling from 90 minutes pre-dose to 48 hours post-dose. The duration of each treatment period is 4 days, with a 7±2 days washout in between of the treatment administration. The follow-up period will be 7±3 days after the last treatment dosing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg Apixaban Oral Dissolving Film (fasting) | Experimental | Drug: 5 mg Apixaban Oral Dissolving Film (fasting)Treatment T1: Subject will receive a single dose of 5 mg Apixaban Oral Dissolving Film under fasting condition |
| 5 mg Apixaban Oral Dissolving Film (fed) | Experimental | Drug: 5 mg Apixaban Oral Dissolving Film (fed)Treatment T2: Subject will receive a single dose of 5 mg Apixaban Oral Dissolving Film under fed condition. |
| 5 mg Apixaban Oral Tablet (US RS/RLD) | Active comparator | Drug: 5 mg Apixaban Oral Tablet (US RS/RLD)Treatment R1: Subject will receive a single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) under fasting condition. |
| 5 mg Apixaban Oral Tablet (EU product) | Active comparator | Drug: 5 mg Apixaban Oral Tablet (EU product)Treatment R2: Subject will receive a single dose of 5 mg Apixaban Oral Tablet (EU product)) under fasting condition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- 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.
Key exclusion criteria (30 listed)
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- The subject has a history of severe allergic or anaphylactic reactions.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg Apixaban Oral Dissolving Film (fasting)Also: TAH3311 ODFSingle dose of 5 mg Apixaban Oral Dissolving Film will be administered orally after at least 10 hours overnight fast | Drug | 5 mg Apixaban Oral Dissolving Film (fasting) |
| 5 mg Apixaban Oral Dissolving Film (fed)Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that is preceded by at least 10 hours overnight fast | Drug | 5 mg Apixaban Oral Dissolving Film (fed) |
| 5 mg Apixaban Oral Tablet (US RS/RLD)Also: ELIQUIS® (US RS/RLD)Single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) will be administered orally after at least 10 hours overnight fast | Drug | 5 mg Apixaban Oral Tablet (US RS/RLD) |
| 5 mg Apixaban Oral Tablet (EU product)Single dose of 5 mg Apixaban Oral Tablet (EU product) will be administered orally after at least 10 hours overnight fast | Drug | 5 mg Apixaban Oral Tablet (EU product) |
Primary outcome
Peak Plasma Concentration (Cmax) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions
Time frame: From enrollment to the end of treatment at 10 weeks
Peak Plasma Concentration (Cmax) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Time frame: From enrollment to the end of treatment at 10 weeks
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
Time frame: From enrollment to the end of treatment at 10 weeks
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
Time frame: From enrollment to the end of treatment at 10 weeks
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
Time frame: From enrollment to the end of treatment at 10 weeks
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for ELIQUIS® 5 mg Oral Tablet under fasted condition
Time frame: From enrollment to the end of treatment at 10 weeks
3 secondary outcomes
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
Time frame: From enrollment to the end of treatment at 10 weeks
Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban for ELIQUIS® 5mg Oral Tablets (for the EU product) under fasted conditions
Time frame: From enrollment to the end of treatment at 10 weeks
Obtaining specific pharmacokinetic parameters for Apixaban following single dose administration under fasted and fed conditions:
Time frame: From enrollment to the end of treatment at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany A Bradley, MD principal investigator
Novum Pharmaceutical Research Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed) and 5 mg Apixaban Oral Tablet (US RS/RLD) in people with Random Allocation and Intermittent Fasting, run by TAHO Pharmaceuticals Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions (time frame: From enrollment to the end of treatment at 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.