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

NCT06930937 | Completed

• 1 other identifier: Protocol No.: C1B03118
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Stroke or Systemic Embolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)

Outcome Measures

Primary Outcomes (2)

• Maximum measured plasma concentration over the time span specified (Cmax)

  acceptance range for 90% confidence interval was considered within 80.00% to 125.00% to establish bioequivalence for Cmax parameter.

  36 hours

• 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)

  The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00% for Edoxaban to establish bioequivalence

  36 hours

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve to infinity (AUCi)

  36 hours

• Time of the maximum measured plasma concentration (Tmax)

  36 hours

Study Arms (2)

Edoxaban Film Coated Tablet

EXPERIMENTAL

Edoxaban Film Coated Tablet (60 mg)

Other: Lixiana® Film Coated Tablet; Other: Edoxaban Film Coated Tablet

Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban)

ACTIVE COMPARATOR

Other: Lixiana® Film Coated Tablet; Other: Edoxaban Film Coated Tablet

Interventions

Lixiana® Film Coated Tablet OTHER

Lixiana® 60 mg filmtabletten (Film Coated Tablet) (Edoxaban)

Edoxaban Film Coated Tablet; Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban)

Edoxaban Film Coated Tablet OTHER

Edoxaban 60 mg Film Coated Tablet

Edoxaban Film Coated Tablet; Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 382210, India

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: August 30, 2024
• Primary Completion: October 25, 2024
• Study Completion: November 11, 2024
• Last Updated: April 20, 2025

Record last verified: 2024-11

Locations

IN (1)