Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers

NCT06689436 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TAH3311-CP-2301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Random Allocation; Intermittent Fasting; Enteral Feeding

Keywords

Crossover Design; Therapeutic Equivalency

Outcome Measures

Primary Outcomes (6)

• Peak Plasma Concentration (Cmax) of Apixaban for TAH3311 Oral Dissolving Film (ODF) under fasted and fed conditions

  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

  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

  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

  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

  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

  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

  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

  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:

  From enrollment to the end of treatment at 10 weeks

Study Arms (4)

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

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.

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.

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.

Drug: 5 mg Apixaban Oral Tablet (EU product)

Interventions

5 mg Apixaban Oral Dissolving Film (fasting) DRUG

Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally after at least 10 hours overnight fast

Also known as: TAH3311 ODF

5 mg Apixaban Oral Dissolving Film (fasting)

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 Dissolving Film (fed)

5 mg Apixaban Oral Tablet (US RS/RLD) DRUG

Single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) will be administered orally after at least 10 hours overnight fast

Also known as: ELIQUIS® (US RS/RLD)

5 mg Apixaban Oral Tablet (US RS/RLD)

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

5 mg Apixaban Oral Tablet (EU product)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TAHO Pharmaceuticals Ltd.: lead

Study Sites (1)

Novum Pharmaceutical Research Services, USA

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Intermittent Fasting

Interventions

apixaban

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Tiffany A Bradley, MD

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: November 16, 2024
• Primary Completion: January 15, 2025
• Study Completion: April 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (1)