CTRI/2020/12/029514尚未招募未知
An Open Label, Balanced, Randomized, Three-Treatment, Single-Period, Single Oral Dose, Parallel, Exploratory Pharmacokinetic Study Of Thymoquinone Tablet 12.5 mg, 25 mg, 50 mg In Normal, Healthy, Adult, Human Subjects Under Fasting Condition
试验速览
- 阶段
- 未知
- 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-smoker, Normal, healthy, adult, human volunteers between 18 to 45 years of age (both inclusive).
- •b)Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive).
- •c)Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
- •d)Able to understand and comply with the study procedures, in the opinion of the investigator.
- •e)Able to give voluntary written informed consent for participation in the study.
- •f)In case of female subjects:
- •i.Surgically sterilized at least 6 months prior to study participation
- •ii.If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •iii.Serum pregnancy test must be negative.
排除标准
- •a)Known hypersensitivity to Thymoquinone or any excipients or any related 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)Ingestion of medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to 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)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 07 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 percentage distilled spirits, such as rum, whisky, brandy etc.), or consumption of alcohol or alcoholic product within 48 hours prior to dosing.
- •f)Smokers or who have smoked within last 06 months prior to start of the study.
- •g)The presence of clinically significant abnormal laboratory values during screening.
- •h)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •i)History or presence of seizure or psychiatric disorders.
- •j)History of difficulty in donating blood.
- •k)Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •l)Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to dosing 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.)
- •m)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •n)A positive test result for HIV antibody (1 and / or 2).
- •o)Difficulty in swallowing solids dosage forms like tablets or capsules.
- •p)Positive for pregnancy test (for female subjects).
- •q)Consumption of grapefruit or grapefruit products within 72 hours prior to dosing.
- •r)An unusual diet, for whatever reason (for example, fasting, high potassium or 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.
- •s)Nursing mothers (for female subjects).
研究者
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