Bioequivalence Study of Apixaban 5 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions
- Trial ID
- 2023-506844-18-00
- Protocol
- CFA-1028-2-23
- Sponsor
- Laboratorios Cinfa S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of Apixaban 5 mg film-coated tablets in healthy subjects under fasting conditions. Bioequivalence studies are crucial in determining whether a generic version of a drug releases its active ingredient into the bloodstream at the same rate and extent as the original branded drug. This is clinically relevant as it ensures that the generic product will have the same therapeutic effect and safety profile as the branded version, which is essential for maintaining consistent patient care and treatment outcomes.
Participants
The clinical trial involves a **study population** that includes both male and female participants, with an **age range** category code of 3, indicating a specific age group as defined by the trial's criteria. The trial population is noted to include a **vulnerable population**, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Participants were selected without any specific **medical condition** being a requirement, as the trial does not focus on a particular disease or health issue. Information regarding lifestyle considerations such as diet, physical activity, or habits has not been provided. The sponsor has not given information on key inclusion or exclusion criteria, nor the main objective of the trial.
Plans and Procedures
The clinical trial is designed to evaluate the **bioequivalence** of Apixaban 5 mg film-coated tablets in healthy subjects under fasting conditions. This study is a Phase 2 trial, which is categorized as a randomized, double-blind, controlled trial. The estimated recruitment start date is December 26, 2023, with an anticipated end date of January 18, 2024. The trial does not involve any specific medical condition, as it is conducted with healthy participants.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive the investigational product or a control. The trial will include multiple follow-up visits to monitor the participants' health and collect necessary data. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis.
The expected length of participant involvement is approximately three weeks, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is structured to ensure the safety and well-being of participants while providing robust data on the bioequivalence of the investigational product.
Treatment
The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.
In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. Consequently, the trial documentation lacks comprehensive information on the treatment protocols and methodologies employed in the study.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on December 26, 2023, with an estimated end date of January 18, 2024. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 2 trials, focusing on evaluating the efficacy of the intervention under investigation. The trial's design will ensure that efficacy assessments are conducted in a manner consistent with clinical research protocols, although specific tools or instruments for efficacy evaluation are not specified in the provided information.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- Male or female participant between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on vital signs.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobaccoor nicotine-containing products for at least 6 months (180 days) prior to Screening).
- A female participant is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until the end of study.
Exclusion Criteria
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or participant safety.
- History of drug or alcohol abuse.
- Known hereditary galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
- History of significant bleeding episode (i.e., symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin levels of 2 g/dL or greater, or leading to a transfusion of ≥2 U of whole blood or red blood cells).
- History of significant coagulation disorders (e.g., hemophilia, Von Willebrand disease, clotting factor deficiencies, hypercoagulable states and deep venous thrombosis).
- History of hepatic disease associated with coagulopathy and bleeding risk.
- Presence of clinically significant active bleeding.
- Presence of any lesion or condition considered to be a significant risk for major bleeding, as assessed by the Investigator.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months (180 days).
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months (180 days).
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines within the previous 6 months (180 days).
- Participation in any clinical trial within the previous 2 months (60 days).
- Participation in more than 2 clinical trials within the previous 12 months (360 days).
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months (60 days).
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman of childbearing potential, positive pregnancy test.
- If woman, is breast-feeding.
- Any other condition that the Investigator considers to render the participant unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the participant at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or non-prescription medicinal products, vitamins, food supplements, mineral, or herbal supplements within 4 weeks prior to admission to Period 1 until the end of study, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise participant safety.
- Use of any liver-toxic drug or systemic drug known to substantially alter liver metabolism within the previous 90 days prior to admission to Period 1 until the end of study, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
- Consumption of chewing gum within the previous 48 hours.
- Performance of strenuous physical exercise within the previous 48 hours.
- Positive result in drugs-of-abuse or ethanol tests.
- If WOCBP, positive pregnancy test.
- Any other condition that the Investigator considers to render the participant unsuitable for the study period.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Portugal | Not Recruiting | 26 Dec 2023 | 24 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Apixaban 5 mg film-coated tablets | Test | FILM-COATED TABLET | ORAL USE | 5 | 1 | PRD10787342 |
Eliquis 5 mg film-coated tablets | Comparator | FILM-COATED TABLETS | ORAL USE | 5 | 1 | PRD2351290 |