CTRI/2025/09/094030尚未招募不适用
An open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover food effect study of ND 10 (7-Methylxanthine, a caffeine derivative) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) of Theialife Inc. when administered under fasting and fed conditions in normal, healthy, adults.
Dr AKBAR WAJID1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年9月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate the effect of food on bioavailability of ND 10 (7- Methylxanthine) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) of Theialife Inc. when administered under fasting and fed conditions in normal, healthy, adults.
研究概览
简要总结
Participants 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. Participants must be enrolled in the study only after providing written informed consent. Selection of Participants 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 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy, adult human male participants 18 to 55 years of age both inclusive and weight 50 Kg BMI 18.5 to 30.0 kg per m² including both.
- •Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and chest X Ray postero anterior view.Values of laboratory parameters within normal range or clinically non significant as determined by the investigator or physician.
- •Participants able to communicate effectively.
- •Participants willing to give written informed consent and adhere to all the requirements of this protocol.
- •Participant willing to abstain from all kinds of alcoholic beverages smoking or tobacco products caffeine or xanthine containing foods or juices or grapefruit or grapefruit juice from 72.00 hours prior to admission until the last post dose blood sample collection in each period.
排除标准
- •Participants having history of contraindication or hypersensitivity e.g. anaphylaxis to ND 10 7 Methylxanthine or related group of drugs such as caffeine theobromine.
- •A history of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease or 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.
- •Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
- •Any known drugs that inhibit the adenosine within 14 days before the study.
- •Participation in a drug research study within 90 days prior to dosing of this study.
- •Blood loss or whole blood donation within 90 days prior to drug administration.
- •History of addiction to any recreational drug or drug dependence.
- •An unusual or abnormal diet for whatever reason within 48.00 hours prior to admission of each period e.g. fasting due to religious reasons.
- •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 consumption tests during the study admission of each period.
- •History of pre existing bleeding disorder.
- •Difficulty with drawing blood.
- •Difficulty in swallowing Investigational products.
- •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 or minute or more than 100 beats or minute.
- •Use of any prescribed medication or OTC medicinal products including vitamins and herbal medicinal products during last two weeks preceding the first dosing.
结局指标
主要结局
To evaluate the effect of food on bioavailability of ND 10 (7- Methylxanthine) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) of Theialife Inc. when administered under fasting and fed conditions in normal, healthy, adults.
时间窗: Assessment of food effect for Treatment A and Treatment B will be calculated and reported for ln-transformed pharmacokinetic parameters | Cmax, AUC0-t and AUC0-inf for ND 10 (7-Methylxanthine)
次要结局
- To assess the safety and tolerability of ND 10 (7-Methylxanthine) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) in normal, healthy, adults, under fasting and fed conditions.(The safety of the subjects will be monitored during the study The adverse events will be reported accordingly)
研究者
Dr Mallu Maheswara Reddy
Jeevan Scientific Technology Ltd
研究点 (1)
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