CTRI/2019/02/017597尚未招募1 期
A RANDOMIZED, PHASE-I, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-ESCALATION(SINGLE ASCENDING DOSE) STUDY TO EVALUATE SAFETY, TOLERABILITY &PHARMACOKINETICS OF HRF-4467 SOLUTION OF HETERO LABS LIMITED, INDIA INNORMAL, HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION ANDEVALUATION OF FOOD EFFECT WITH ANY ONE COHORT OF SINGLE ASCENDING DOSE
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
- •a) Non-smoking, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive) living in and around
- •Ahmedabad city or western part of India.
- •b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg per height in meter square.
- •c) Volunteer should be literate
- •d) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- •e) Able to understand and comply with the study procedures, in the opinion of the principal/Coinvestigator.
- •f) Able to give voluntary written informed consent for participation in the trial.
排除标准
- •a) Known hypersensitivity or idiosyncratic reaction to normally used medicines such as antihistamines, NSAIDs or any of the excipients
- •or related drug.
- •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) Ingestion of a medicine (CYP inducers or inhibitors including herbal medicines) at any time within 14 days before dosing. In any
- •such case subject selection will be at the discretion of the Principal Investigator.
- •d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •f) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A
- •standard drink is defined as 360 ml of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy
- •etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing.
- •g) Smokers, or who have smoked within last six months prior to start of the study.
- •h) The presence of clinically significant abnormal laboratory values during screening.
- •i) History or presence of seizure or psychiatric disorders.
- •j) A history of difficulty in donating blood.
- •k) Difficulty in swallowing tablet/capsule.
- •l) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •m) 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
- •n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •o) A positive test result for HIV (I & II) antibody.
- •p) Consumption of Grapefruits or its products within 72 hours prior to dosing.
- •q) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator.
研究者
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