CTRI/2023/04/051381已完成1 期
An open label, Phase-1, parallel, dose-escalation, comparative pharmacokinetic,safety and tolerability study of Ursodiol injection 625mg/25ml (25mg/ml) at different dose levels (600 mg, 900 mg, 1800 mg & 3500 mg) with oral administration ofACTIGALL (Ursodiol) capsules 300 mg (Dose 900 mg) in healthy subjects under fedconditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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
- •1. Healthy human subjects between 18-45 years of age (including both) and weight = 50 Kg (BMI 18.00- 25.00 kg/m²).
- •2. Acceptable findings during registration and screening including, detailed medical history, full physical examination, medical examination, laboratory evaluations, 12- lead ECG and Chest X-Ray (postero-anterior view).
- •3. Values within Normal Ranges of Laboratory Parameters upon evaluation by the Investigator or Physician.
- •4. Subjects able to communicate effectively.
- •5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •6. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 96.00 hours before admission till the last blood sample in study period.
- •7. Male Subjects:
- •Subjects willing to follow approved birth
- •control methods (a double barrier method) for
- •the duration of the study as judged by the
- •investigator(s), such as (a double barrier
- •method) Condom with spermicide, Condom with
- •diaphragm, or abstinence, Subjects should also not donate
- •sperm during this time.
- •8. Female subjects:
- •Postmenopausal for at least 1 year or
- •Surgically sterile (bilateral tubal ligation,
- •bilateral oophorectomy or
- •hysterectomy has been performed on the subject)
排除标准
- •1. Volunteers having history of contraindication or hypersensitivity (e.g.,
- •anaphylaxis) to ursodeoxycholic acid or other related drugs, or related group of
- •2. A history or presence of significant asthma, urticaria, or other allergic-type
- •reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylacticlike
- •reactions to NSAIDs, seizures, diabetes, migraine, hypertension,
- •cardiovascular, pulmonary, neurological or psychiatric disease/disorder,
- •dermatological, endocrine, eye disorders, immunological, 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.
- •3. History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration,
- •and perforation of the stomach, small intestine, or large intestine.
- •4. History or presence of hepatic, thyroid, or renal dysfunction.
- •5. History or presence of bronchial asthma.
- •6. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS),
- •and toxic epidermal necrolysis (TEN).
- •7. Any known enzyme inducing or inhibiting drug taken within 30 days before the
- •8. A depot injection or implant of any drug within 3 months prior to the dose of
- •study medication.
- •9. Use of CYP enzyme inhibitors or inducers within 30 days prior to the dose of
- •study medication
- •10. Participation in a drug research study within 90 days prior to dosing of this study.
- •11. Blood loss or whole blood donation within 90 days prior to drug administration.
- •12. Current use or anticipated need for drugs with known or suspected interactions
- •with ursodeoxycholic acid.
- •13. Subjects with hypertension or cardiovascular risk factors.
- •14. Consumption of high caffeine (more than 5 cups of coffee or tea/day).
- •15. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day
- •or those who cannot refrain from smoking during the study period.
- •16. History of addiction to any recreational drug or drug dependence.
- •17. An unusual or abnormal diet, for whatever reason within 96.00 hours prior to
- •admission of study period, e.g. fasting due to religious reasons.
- •18. History of dehydration from diarrhea, vomiting or any other reason within a
- •period of 96.00 hours prior to study admission of study period.
- •19. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids,
- •amphetamines, cannabinoids and barbiturates) in urine during the study
- •admission of study period.
- •20. Positive results for alcohol consumption tests during the study admission.
- •21. History of pre-existing bleeding disorder.
- •22. Difficulty with donating blood.
- •23. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •24. 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.
- •26. Use of any prescribed medication or OTC medicinal products and herbal
- •medicines during last two weeks preceding the first dosing.
- •27. Female volunteer who is pregnant, currently breast-feeding.
- •28. Female subjects demonstrating a positive pregnancy test.
- •29. Female vo
研究者
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