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.

Zuventus Healthcare Limited1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年6月29日最近更新: 2024年5月3日

试验速览

阶段: 不适用
状态: 已完成
发起方: Zuventus Healthcare Limited
入组人数: 40
试验地点: 1
主要终点: To demonstrate the bioequivalence between Test Product, Edoxaban 60

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•Subjects will be selected to participate in the study, if they meet all of the following criteria:
•Healthy, adult, human subjects age between 18 to 45 years old, both inclusive and weight â‰¥ 60 Kg (BMI 18.5 to 29.9 kg/mÂ²).
•Subjects able to communicate effectively.
•Voluntary participation.
•Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
•Normal 12-lead ECG.
•Normal chest X-ray.
•Normal laboratory parameters.
•Creatinine clearance > 80 mL/min
•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 johnâ€™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).

排除标准

•Volunteers with a history of contraindication or hypersensitivity (e.g., anaphylaxis) to Edoxaban related class of drugs and any of its ingredients.
•Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study.
•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.
•History of any current or previous malignacies.
•History of factor V Leiden, ATIII deficiency, antiphospholipid syndrome or any other thrombotic or thromboembolic complications.
•Any history of brain, spinal or ophthalmic surgery in the last 1 year prior to admission.
•Any history of known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
•Any history of current or recent gastrointestinal ulceration or bleeding
•History of intracranial haemorrhage.
•History or evidence of exfoliative dermatitis, Stevens.
•Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
•Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
•Participation in a drug research study within 90 days prior to dosing of this study.
•Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug administration.
•A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
•Intolerance to venipuncture.
•History of addiction to any recreational drug or drug dependence.
•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.
•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.
•Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
•Positive results for alcohol consumption during the admission of each study period.
•History of pre-existing bleeding disorder.
•Difficulty with donating blood.
•Difficulty in swallowing oral solid investigational products.
•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.
•Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
•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.
•Females with positive results on serum pregnancy test.
•Females currently breast-feeding.
•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.