CTRI/2018/01/011259已完成1 期
A Phase-I, Dose Escalation Study to evaluate safety, tolerability and pharmacokinetic of ICB-014-A002 capsule in healthy adult volunteers.
Indian Institute of Integrative Medicine Council of Scientific Industrial Research0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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 adult volunteers within age group of 18-55 years.
- •2. BMI in the range of 18.50 â?? 24.90 kg/m2 (both inclusive).
- •3. Volunteers with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor.
- •4. Free of any acute/chronic illness and should not be on treatment for any prior illness.
- •5. Non-smokers or non-alcoholic.
- •6. Volunteer must be willing to provide written informed consent and comply with the requirements of the study.
排除标准
- •1. Volunteer incapable of understanding the informed consent process / procedure.
- •2. Volunteer who have taken a PPI or a H2 blocker or prokinetic agent or any other gastroprotective agent within seven days of screening
- •3. Volunteer with known history of any clinically significant medical diseases, hematology, biochemistry or urine analysis will be excluded from the study unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study.
- •4. Volunteer who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical study
- •5. Volunteer who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
- •6. Investigations with blood samples of the volunteer shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses.
- •7. Positive test for urinary screen testing of drugs of abuse.
- •8. Volunteer found positive for alcohol breath test.
- •9. Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing or alcoholic products consumption within 48 hours prior to the dosing.
- •10. Volunteer who have consumed â??Grape fruitâ?? or its juice within 72 hours prior to dosing of each period.
- •11. Female volunteers who are found positive in Urinary Pregnancy Test or are lactating.
- •12. Female volunteers who are using any type of hormonal contraceptives.
- •13. Volunteer who participated in any other clinical investigation using experimental drug or had bleed more than 300 ml in the past 3 months.
- •14. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
研究者
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