CTRI/2023/06/054295已完成Unknown
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. - Nil
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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)
排除标准
- •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 abus
研究者
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