Prevention of Stroke or Systemic EmbolismNCT06930937
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
A study testing Lixiana® Film Coated Tablet and Edoxaban Film Coated Tablet in people with Prevention of Stroke or Systemic Embolism and Deep Vein Thrombosis (DVT), run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- What is being tested?
- Lixiana® Film Coated Tablet and Edoxaban Film Coated Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 30 Aug 2024to 11 Nov 2024
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female.
- 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:
- 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.
- Female was not considered of child-bearing potential if one of the following was reported and documented on the medical history:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Four-period, Twotreatment, Two-sequence, Fully Replicate, Crossover, Balanced, Single Dose Oral Bioequivalence Study
- 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)
- Being tested
- Lixiana® Film Coated Tablet, Edoxaban Film Coated Tablet
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixiana® Film Coated TabletOther
Lixiana® 60 mg filmtabletten (Film Coated Tablet) (Edoxaban)
Edoxaban Film Coated TabletOther
Edoxaban 60 mg Film Coated Tablet
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban Film Coated Tablet | Experimental | Edoxaban Film Coated Tablet (60 mg) Receives: Other: Lixiana® Film Coated Tablet; Other: Edoxaban Film Coated Tablet |
| Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban) | Active comparator | Not described Receives: Other: Lixiana® Film Coated Tablet; Other: Edoxaban Film Coated Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 36 hours
Secondary outcomes (2)
Area under the plasma concentration versus time curve to infinity (AUCi)
Descriptive Statistics
Measured: 36 hours
Time of the maximum measured plasma concentration (Tmax)
Descriptive Statistics
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start30 Aug 2024
- Primary completion25 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Stroke or Systemic EmbolismStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930937
- Sponsor's protocol ID
- Protocol No.: C1B03118
- Status last verified
- Nov 2024
- First submitted
- 9 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Four-period, Twotreatment, Two-sequence, Fully Replicate, Crossover, Balanced, Single Dose Oral Bioequivalence Study
- ClinicalTrials.gov ID
- NCT06930937
- Acronym / sponsor ID
- Protocol No.: C1B03118
- Conditions
- Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 16 Apr 2025 (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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban Film Coated Tablet | Experimental | Other: Lixiana® Film Coated Tablet, Other: Edoxaban Film Coated TabletEdoxaban Film Coated Tablet (60 mg) |
| Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban) | Active comparator | Other: Lixiana® Film Coated Tablet, Other: Edoxaban Film Coated Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female.
- 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:
- 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.
- Female was not considered of child-bearing potential if one of the following was reported and documented on the medical history:
Key exclusion criteria (31 listed)
- 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.
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 |
|---|---|---|
| Lixiana® Film Coated TabletLixiana® 60 mg filmtabletten (Film Coated Tablet) (Edoxaban) | Other | Edoxaban Film Coated Tablet, Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban) |
| Edoxaban Film Coated TabletEdoxaban 60 mg Film Coated Tablet | Other | Edoxaban Film Coated Tablet, Lixiana® filmtabletten (Film Coated Tablet) (Edoxaban) |
Primary outcome
Maximum measured plasma concentration over the time span specified (Cmax)
Time frame: 36 hours
acceptance range for 90% confidence interval was considered within 80.00% to 125.00% to establish bioequivalence for Cmax parameter.
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)
Time frame: 36 hours
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
2 secondary outcomes
Area under the plasma concentration versus time curve to infinity (AUCi)
Time frame: 36 hours
Time of the maximum measured plasma concentration (Tmax)
Time frame: 36 hours
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 20 Apr 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lixiana® Film Coated Tablet and Edoxaban Film Coated Tablet in people with Prevention of Stroke or Systemic Embolism and Deep Vein Thrombosis (DVT), run by Humanis Saglık Anonim Sirketi at 1 site in India.
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 13 inclusion and 31 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 20 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 India. 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.
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?
Maximum measured plasma concentration over the time span specified (Cmax) (time frame: 36 hours). The study lists 2 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 20 Apr 2025.