CTRI/2019/12/022297尚未招募1 期
A Randomized, Phase-I, Double-Blind, Placebo-Controlled, Multiple Cohort, Multiple Ascending Dose (dose-escalation) study to Evaluate Safety and Tolerability of Aqueous Extract of Cocculus Hirsutus (AQCH Tablet) (Of Sun Pharmaceutical Industries Limited India) in Healthy Adults Human Subjects under Fasting Condition
Sun Pharmaceutical Industries Limited India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
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
- •a) Non-smokers, Healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
- •b) Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/height in m2.
- •c) Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
- •d) Able to understand and comply with the study procedures, in the opinion of the investigator.
- •e) Able to give voluntary informed consent for participation in the trial.
- •f) Male subjects should agree to comply with effective contraceptive methods for the entire duration and refrain from fathering a child for at least 4 weeks following last study drug administration
- •g) In case of female subjects:
- •i. Surgically sterilized at least 6 months prior to study participation;
- •ii. Serum pregnancy test must be negative
排除标准
- •a. Known hypersensitivity or idiosyncratic reaction to AQCH Tablet or to any of its excipients or any drug or any substance.
- •b. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •c. Sitting blood pressure less than 110/70 mm Hg and/or more than 140/90 mm Hg at the time of screening.
- •d. Ingestion of a medicine [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 2 weeks before first dosing (4 weeks for any drug which may affect hepatic drug metabolism). In any such case subject selection will be at the discretion of the Principal Investigator.
- •e. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •f. Consumption of Grapefruits or its products within a period of 72 hours prior to first IMP administration.
- •g. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or Consumption of alcohol or alcoholic products within 48 hours prior to first IMP administration.
- •h. Smokers or who have smoked within last 06 months prior to start of the study.
- •i. Difficulty in swallowing solids dosage forms like tablets.
- •j. The presence of clinically significant abnormal laboratory values during screening.
- •k. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •l. A history of difficulty with donating blood.
- •m. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •n. Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
- •If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •o. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •p. A positive test result for HIV antibody (I &/or II).
- •q. Subjects having tattoo or body piercing within 30 days prior to first dose of the study
- •r. Screening ECG results with QTcF >450 msec (male) or >470 msec (female) or QRS >120 msec and PR interval > 200msec
- •s. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to first IMP administration. In any such case subject selection will be at the discretion of the Principal Investigator.
- •t. Nursing mothers (females)
- •u. Lab abnormalities that are clinically significant at screening, and which, in opinion of investigator, will impact the safety assessments
研究者
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