CTRI/2020/09/027808招募中1 期
A PHASE-I, SINGLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ADRENATABâ?¢ SUBLINGUAL TABLET RELATIVE TO INTRAMUSCULAR OR SUBCUTANEOUS FORMULATIONS OF EPINEPHRINE IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITIO
Belcher Pharmaceuticals0 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
- 招募中
- 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-smoking, normal, healthy adult human volunteers between 18 to 40 years of age (both inclusive).
- •b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in meter2.
- •c) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG, TMT, Echocardiography and X-ray chest (P/A view) recordings.
- •d) Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- •e) Able to give voluntary written informed consent for participation in the trial.
- •f) Postmenopausal women with serum FSH levels between 25.8-134.8 mIU/mL.
- •g) In case of female subjects:
- •i. Surgically sterilized at least 6 months prior to study participation
- •If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •h) Serum pregnancy test must be negative.
排除标准
- •i) Known hypersensitivity or idiosyncratic reaction to Epinephrine and normally used medicines such as anti-histamines, NSAIDs or any of the excipients or related drug.
- •j) 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.
- •k) Ingestion of Monoamine oxidase (MAO) inhibitors from 30 days, prescription medication from 14 days, over-the-counter products including herbal remedies from 7 days prior to the first dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
- •l) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •m) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •n) 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 male and more than 7 standard drinks per week for female (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 dosing period I.
- •o) Smokers, or who have smoked within last six months prior to start of the study.
- •p) Consumption of Epipen within last six months prior to start of the study.
- •q) The presence of clinically significant abnormal laboratory values during screening.
- •r) History or presence of seizure or psychiatric disorders.
- •s) A history of difficulty in donating blood.
- •t) Difficulty in swallowing tablet/capsule.
- •u) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •v) 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.
- •w) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •x) A positive test result for HIV (1 &/ or 2) antibody.
- •y) Consumption of grapefruit or grapefruit products, pomegranate, pineapple, or pomelo from 7 days prior to dosing.
- •z) Consumption of Food containing poppy seeds from 24 hours prior to dosing
- •aa) 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.
- •bb) Nursing mothers (for female subjects).
研究者
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