Clinical trial NCT06930937: To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions
Official title: An Open Label, Randomized, Four-period, Twotreatment, Two-sequence, Fully Replicate, Crossover, Balanced, Single Dose Oral Bioequivalence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Stroke or Systemic Embolism
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Lead sponsor: Humanis Saglık Anonim Sirketi
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: * To compare and evaluate the oral bioavailability of Edoxaban 60 mg Film Coated Tablet with that of Lixiana® 60 mg filmtabletten (Film Coated Tablet (Edoxaban) in healthy, adult, human subjects under fasting conditions.
* To monitor the safety and tolerability of the subjects.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 55 years old, both inclusive.
* Gender: Male and/or non-pregnant, non-lactating female.

A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β HCG) pregnancy test performed within 28 days prior to first dosing day. They used an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception included the following:

i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.

B. Female was not considered of child-bearing potential if one of the following was reported and documented on the medical history:

i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.

* BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value was rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
* Volunteers had a body weight of more than 60 kg
* Non-smokers and non-tobacco users (i.e. had no past history of smoking and tobacco consuming for at least one year prior to study).
* Able to communicate effectively with study personnel.
* Willing to provide written informed consent to participate in the study.
* All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:

  1. A physical examination (clinical examination) with no clinically significant finding.

Exclusion Criteria

* History of allergic responses to Edoxaban or other related drugs, or any of its formulation ingredients.
* Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
* Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
* History or presence of bronchial asthma.
* Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
* Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
* Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
* History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
* History of difficulty with donating blood or difficulty in accessibility of veins.
* A positive hepatitis screen (includes subtypes B \& C).
* A positive test result for HIV antibody.
* Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
* Volunteers who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
* History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
* Intolerance to venipuncture
* Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
* Institutionalized volunteers.
* Used any prescribed medications \[including aspirin and other antiplatelet agents, antithrombotic agents, fibrinolytic therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors\] within 14 days prior to the first dose of study medication.
* Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
* Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
* Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
* Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
* Volunteer had a platelet count below the lower limit of the normal range during screening.
* Volunteer had an INR and Prothrombin Time and/or Activated Partial Thromboplastin Time value higher than 1.1 times of the upper limit of normal ranges during screening.
* Volunteers had SGPT, SGOT and alkaline phosphatase values 1.1 times higher than the upper limit of normal range during screening.
* Volunteers had serum bilirubin value higher than the upper limit of normal range during screening.
* History of bleeding disorders or any significant family history of bleeding disorders.
* History of prosthetic heart valve or history of pulmonary embolism.
* History of traumatic or repeated epidural or spinal puncture or plan for spinal surgery/spinal procedure or volunteer having any spinal deformity or neurological impairment.
* Creatinine clearance below 60 mL/min during screening.
* History or presence of active pathological bleeding.

Primary outcomes:
measure: Maximum measured plasma concentration over the time span specified (Cmax)
timeFrame: 36 hours
measure: The area under the plasma concentration versus time curve was calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt)
timeFrame: 36 hours
Secondary outcomes:
measure: Area under the plasma concentration versus time curve to infinity (AUCi)
timeFrame: 36 hours
measure: Time of the maximum measured plasma concentration (Tmax)
timeFrame: 36 hours
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Cliantha Research Limited
state: Gujarat
Study officials:
References: