CTRI/2024/02/062928已完成不适用
An open label balanced randomized two-treatment two-period two-sequence multiple-dose steady state crossover comparative bioavailability study of ND 10 (7-Methylxanthine, a caffeine derivative) Extended-Release Tablets 500 mg of Theialife Sciences comparing with ND 10 (7-Methylxanthine a caffeine derivative) Immediate Release Tablets 400 mg of Theialife Sciences in healthy adult human subjects under fed conditions
Dr AKBAR WAJID1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年3月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To compare the bioavailability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences comparing with ND 10 (7 Methylxanthine, a caffeine derivative) Immediate Release Tablets 400 mg of Theialife Sciences in healthy adult human subjects under fed conditions
研究概览
简要总结
Subjects will undergo a screening procedure comprising clinical examination, recording of electrocardiogram and laboratory investigation of blood as well as urine which will be valid for 21 days from the day of screening. Radiological investigations (chest X-ray) will be repeated, if not done in the past 6 months or if clinically indicated at the time of screening. Subjects must be enrolled in the study only after providing written informed consent. Selection of subjects for the study will be done based on assessment against the inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
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 each 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 urticaria 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 Xray 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 of each period, e.g. 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 of each period Positive results for drugs of abuse (benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates) in urine during the study admission of each period Positive results for alcohol (breath analysis urine alcohol blood alcohol) consumption test during the study admission of each study period 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.
结局指标
主要结局
To compare the bioavailability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences comparing with ND 10 (7 Methylxanthine, a caffeine derivative) Immediate Release Tablets 400 mg of Theialife Sciences in healthy adult human subjects under fed conditions
时间窗: ER Tablets 500 mg On dosing day 3 and 4, two time points each day at 0 hours and at 12 hour On dosing day 5, 27 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,12.5,13,13.5,14,14.5,15,15.5,16,17,18,20,22 and 24 hours IR Tablets 400 mg On dosing day 3 and 4 two time points each day at 0 and 8 hours On dosing day 5, 34 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,8.5,9,9.5,10,10.5,11,11.5,12,13,14,16,16.5,17,17.5,18,18.5,19,19.5,20,21,22 and 24 hours
次要结局
- To assess the safety and tolerability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg and ND 10 (7 Methylxanthine a caffeine derivative) Immediate Release Tablets 400 mg in normal healthy adult human subjects under fed conditions(ER Tablets 500 mg On dosing day 3 and 4, two time points each day at 0 hours and at 12 hour On dosing day 5, 27 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,12.5,13,13.5,14,14.5,15,15.5,16,17,18,20,22 and 24 hours IR Tablets 400 mg On dosing day 3 and 4 two time points each day at 0 and 8 hours On dosing day 5, 34 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,8.5,9,9.5,10,10.5,11,11.5,12,13,14,16,16.5,17,17.5,18,18.5,19,19.5,20,21,22 and 24 hours)
研究者
Dr Chodisetti S S Viprusha
Jeevan Scientific Technology Ltd
研究点 (1)
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