CTRI/2024/02/062927尚未招募Unknown
An open label single treatment single period single strength twice daily dosing bioavailability study of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences in healthy adult human subjects under fed conditions - NA
Dr AKBAR WAJID0 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
- Unknown
- 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
- •Healthy adult human subjects between 18 to 45 years of age including both and weight greater than 50 Kg BMI 18.5 to 24.9 kg per m²
- •Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and Chest X Ray postero anterior view
- •Values within normal ranges of laboratory parameters upon evaluation by the Investigator or Physician
- •Subjects able to communicate effectively with study personnel
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol
- •Subject willing to abstain from all kinds of caffeine xanthine containing foods or grapefruit or grapefruit juice from 72 hours prior to admission until last blood sample collection in study period
- •Female subjects
- •Postmenopausal for at least 1 year or
- •Surgically sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject or
- •Female of childbearing potential practicing an acceptable method of birth control for the duration of the study at least two weeks thereafter as judged by the investigator such as condoms foams jellies diaphragm and intrauterine device IUD or abstinence
排除标准
- •Subjects having a history of contraindication or hypersensitivity example anaphylaxis to ND 10 (7 Methylxanthine a caffeine derivative) or related group of drugs
- •A history of significant asthma urticarial or other allergic type reactions after taking aspirin or other NSAIDs
- •A history of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease disorder dermatological endocrine eye disorders immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician
- •History of gastrointestinal GI inflammation bleeding ulceration and perforation of the stomach small intestine or large intestine
- •History or evidence of exfoliative dermatitis Stevens Johnson syndrome SJS and toxic epidermal necrolysis TEN
- •Have significant diseases or clinically significant abnormal findings during screening medical history physical examination clinical examination laboratory evaluations ECG chest X ray recording etc
- •Any known enzyme inducing or inhibiting drug taken within 14 days before the study
- •Participation in a drug research study within 90 days prior to admission of this study
- •Blood loss or whole blood donation within 90 days prior to drug administration
- •Consumption of high caffeine more than 5 cups of coffee or tea per day
- •History of addiction to any recreational drug or drug dependence
- •An unusual or abnormal diet for any reason within 48 hours prior to admission example fasting due to religious reasons
- •History of dehydration from diarrhea vomiting or any other reason within a period of 72 hours prior to study admission
- •Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the study admission
- •Positive results for alcohol breath analysis urine alcohol blood alcohol consumption test during the study admission
- •History of pre existing bleeding disorder
- •Difficulty in swallowing Investigational products
- •Difficulty with donating blood
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg
- •Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg
- •Pulse rate less than 60 beats per minute or more than 100 beats per minute
- •Use of any prescription drugs within 07 days or at least 5 halflives of the compound whichever period is longer prior to study admission and use of any herbal medicines and any OTC medications including vitamins within 14 days or at least 5 halflives of the compound whichever period is longer prior to study admission
- •Symptoms of COVID19 or positive COVID19 test result within the past 30 days
- •Female subjects demonstrating a positive pregnancy screen
- •Female volunteer who is pregnant or currently breast feeding
- •Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing
研究者
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