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临床试验/CTRI/2018/08/015226
CTRI/2018/08/015226已完成1 期

An Open Label, Randomized, Crossover Study to Compare the Pharmacokinetics of TRC041266 Powder with TRC4186 Tablet under Fasting Condition and to Evaluate the Effect of Food on the Pharmacokinetics of TRC041266 Powder in Healthy Human Subjects

Torrent Pharamceutical Ltd0 个研究点目标入组 36 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
发起方
入组人数
36
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Ba/be

入排标准

入选标准

  • •1.Male and/or female subjects aged 18-65 years (both inclusive).
  • •2.Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with minimum weight of 50 kg.
  • •3.Volunteer willing to provide written informed consent.
  • •4.Ability to adhere to the study restrictions and assessments schedule

排除标准

  • •1. Inability to communicate or co-operate.
  • •2. History of angina, myocardial infarction (MI) or stroke within last 3 months prior
  • •to screening.
  • •3. Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  • •4. History of pre-existing bleeding disorder.
  • •5. Clinically relevant abnormal physical findings at the screening examination,
  • •which would interfere with the objectives of the study.
  • •6. Clinically significant abnormalities in the results of the clinical laboratory tests (at
  • •screening or check-in day (i.e. Day-0)).
  • •7. Clinically significant abnormal ECG (at screening), 2D Echo or Chest X-ray.
  • •8. Pregnant or lactating women or female subjects who are of childbearing potential
  • •and who are neither surgically sterilized nor willing to use reliable contraceptive
  • •methods {i) bilateral tubal occlusion; ii) vasectomised partner and iii) sexual
  • •abstinence iv) barrier method of contraception} and/or female volunteer with
  • •positive urine pregnancy test.
  • •9. Smokers who are unable to stop tobacco consumption during each study period, or
  • •smokers who smokes >10 cigarettes (or equivalent) per Day during last 3 months
  • •prior to Day 1.
  • •10. Positive for HIV, HCV and HbsAg.
  • •11. History of significant blood loss due to any reason, including blood donation in
  • •the past 3 months; or the total blood loss in the last 3 months, including for this
  • •study, exceeds 450 ml.
  • •12. Participation in any study within past 3 months
  • •13. Addiction to alcohol or history of alcohol or drug abuse
  • •14. Intake of hepatic microsomal enzyme inducer/inhibitor drugs in the period within
  • •3 months prior to the first dose of study drug
  • •15. History of consumption of prescribed medication since last 14 days or OTC
  • •medication/ herbal remedies since last 7 days before beginning of the study.
  • •16. Volunteer found to be positive for breath alcohol test.
  • •17. History of malignancy
  • •18. Volunteer found to be positive for opiate, tetrahydrocannabinoid, amphetamine,
  • •barbiturates, benzodiazepines, cocaine based on urine test.
  • •19. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and
  • •diastolic blood pressure less than 60 mmHg or more than 89 mmHg.
  • •20. Pulse rate less than 60/minute or more than 100/minute.
  • •21. Oral temperature less than 95°F or more than 98.9°F.
  • •22. Respiratory rate less than 10/minute or more than 20/minute.
  • •23. History of hypersensitivity reaction/allergy to the investigational product or any
  • •drug chemically similar to the drug under investigation or any of the excipients.
  • •24. Recent History of kidney or liver dysfunction.
  • •25. Volunteers suffering from any psychiatric (acute or chronic) disorder.
  • •26. Existence of any surgical or medical condition, which, in the judgment of the
  • •chief investigator and/or clinical investigator/physician, might interfere with the
  • •absorption, distribution, metabolism or excretion of the drug or likely to
  • •compromise the safety of volunteers
  • •27. Volunteers with left ventricular ejection fraction (LVEF) < 55%

研究者

发起方
Torrent Pharamceutical Ltd

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