CTRI/2020/04/024708尚未招募1 期
An Open Label, Randomized, Multiple-dose, Crossover Study to Compare the OralPharmacokinetics and Safety of TRC041266 Powder with TRC4186 Tablet in HealthyHuman Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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. 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%
- •28. Serum magnesium level more than 2.6 mg/dl in male and 2.5 mg/dl in female.
研究者
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