CTRI/2023/06/054295 [Registered on: 22/06/2023] Trial Registered Prospectively
Last Modified On:
05/03/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Comparative pharmacokinetic study of two different formulations of Edoxaban under fasting conditions.
Scientific Title of Study
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose,
crossover, oral bioequivalence study of Test Product, Edoxaban 60 mg film-coated tablets
(Zuventus Healthcare Limited, India) with Reference Product, Lixiana (Edoxaban) 60mg film coated tablets (Daiichi Sankyo Europe GmbH, 81366 Munich, Germany) in healthy, adult, human
subjects under fasting conditions.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
AR024-22 (Version No.: 01, Date: 22 Dec 2022)
Protocol Number
BE/ND/04/2023
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus
House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station,
Nahur (W), Mumbai
Mumbai MAHARASHTRA 400078 India
Phone
02235060000
Fax
02220812898
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Scientific Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus
House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station,
Nahur (W), Mumbai
Mumbai MAHARASHTRA 400078 India
Phone
02235060000
Fax
02220812898
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Public Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus
House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station,
Nahur (W), Mumbai
3rd and 4th Floors,
Archies Continental, P.
No. 2A, 3, S. No. 1094
and 1095, Adj to
Kukatpally Metro
station, Kukatpally,
Hyderabad 500072 Hyderabad TELANGANA
040-69089999
alekhya.muthukuru@advityresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Vasavi Medical and Research Center, Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy adult human subjects under fasting
conditions
Subjects will be selected to participate in the study, if they meet all of the following criteria:
1. Healthy, adult, human subjects age between 18 to 45 years old, both inclusive and weight
≥ 60 Kg (BMI 18.5 to 29.9 kg/m²).
2. Subjects able to communicate effectively.
3. Voluntary participation.
4. Subjects willing to give written informed consent and adhere to all the requirements of this
protocol.
5. Normal 12-lead ECG.
6. Normal chest X-ray.
7. Normal laboratory parameters.
8. Creatinine clearance > 80 mL/min
9. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL.
10.Subject willing to abstain from all kinds of alcoholic beverages, smoking or chewing tobacco,
pan or pan masala, gutkha, masala (containing betel nut and tobacco), having
caffeine/xanthine containing foods or beverages from 72.00 hours before period 01
admission till the study completion. Subjects willing to abstain from all kinds of
grapefruit/citrus/St john’s wort containing food and juices from at least 07 days prior to
admission until the last blood sample collection in each study period.
11.Female subjects:a) of child bearing potential practicing an acceptable method of birth control for the
duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence. b) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
has been performed on the subject)
ExclusionCriteria
Details
1. Volunteers with a history of contraindication or hypersensitivity (e.g., anaphylaxis) to Edoxaban related class of drugs and any of its ingredients.
2. Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study.
3. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or
psychiatric disease/disorder, dermatological, endocrine, ophthalmic disorder/disease, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases,
or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
4. History of any current or previous malignacies.
5. History of factor V Leiden, ATIII deficiency, antiphospholipid syndrome or any other
thrombotic or thromboembolic complications.
6. Any history of brain, spinal or ophthalmic surgery in the last 1 year prior to admission.
7. Any history of known or suspected oesophageal varices, arteriovenous malformations,
vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
8. Any history of current or recent gastrointestinal ulceration or bleeding
9. History of intracranial haemorrhage.
10. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic
epidermal necrolysis (TEN).
11. Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
12. Participation in a drug research study within 90 days prior to dosing of this study.
13. Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug
administration.
14. A depot injection or implant of any drug within 3 months prior to the first dose of study
medication.
15. Intolerance to venipuncture.
16. History of addiction to any recreational drug or drug dependence.
17. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of
each period, e.g., fasting due to religious reasons.
18. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00
hours prior to study admission of each study period.
19. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines,
cannabinoids and barbiturates) in urine during the admission of each study period.
20. Positive results for alcohol consumption during the admission of each study period.
21. History of pre-existing bleeding disorder.
22. Difficulty with donating blood.
23. Difficulty in swallowing oral solid investigational products.
24. Blood pressure on the day of admission of each study period
a. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
25. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission
of each study period.
26. History of alcohol abuse and/or dependence within six months of the screening visit or
History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
27. Females with positive results on serum pregnancy test.
28. Females currently breast-feeding.
29. Female volunteer who has used implanted or injected hormonal contraceptives anytime
during the 6 months prior to study or used hormonal contraceptives within 14 days before
dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To demonstrate the bioequivalence between Test Product, Edoxaban 60
mg film-coated tablets (Zuventus Healthcare Limited, India) with Reference
product, Lixiana (Edoxaban) 60mg film-coated tablets (Daiichi Sankyo
Europe GmbH, 81366 Munich, Germany) in healthy, adult, human subjects
under fasting conditions
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Edoxaban is a highly selective, direct and reversible inhibitor of FXa, the serine protease located in the final common pathway of the coagulation cascade.This study is designed to demonstrate the bioequivalence between Test Product, Edoxaban 60 mg film-coated tablets (Zuventus Healthcare Limited, India) with Reference product, Lixiana (Edoxaban) 60mg film-coated tablets (Daiichi Sankyo Europe GmbH, 81366 Munich, Germany) in healthy, adult, human subjects under fasting conditions.