CTRI/2025/02/080160尚未招募不适用
A Single-treatment, Single-period Clinical Study to Investigate the Effect of a Single Dose of Glyteine 400 mg Capsules on Time-Dependent Changes of Glutathione Levels in Blood Fractions in healthy human subjects.
Biospecialties International Pty Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年2月18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
- 12
- 试验地点
- 1
- 主要终点
- To investigate the time-dependent changes in glutathione concentrations in blood fractions following the oral administration of Glyteine 400 mg capsules.
研究概览
简要总结
This study is a single-treatment, single-period clinical study to investigate the effect of a single dose of Glyteine 400 mg capsules on time-dependent changes of Glutathione levels in blood fractions in healthy human subjects. A total of 12 subjects aged between 50 to 70 years shall be recruited to evaluate the time-dependent changes in glutathione concentrations in blood fractions, safety & tolerability of orally administered Glyteine 400 mg capsules. Total duration of the study shall be 2 days. Healthy human subjects who are eligible based on inclusion and exclusion criteria shall be recruited in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human subjects (Male and/or Peri to Post menopausal Women) aged between 50 to 70 years (inclusive of both).
- •Volunteers with a BMI between 18.5-30.0 kg/m2 (inclusive of both) and body mass not less than 50.00 kg for male and 45.00 kg for females.
- •Volunteers willing to give written informed consent and adhere to all the requirements of this protocol.
- •Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the dosing.
排除标准
- •Known hypersensitivity to Glyteine or Glutathione or any component of this medication.
- •Incapable of understanding the informed consent information.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological,dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
- •5.History of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), diabetic pre-coma.
- •History or presence of alcoholism or drug abuse.
- •History or presence of Sulphur intolerance.
- •History or presence of asthma, urticaria or other allergic reactions.
- •History or presence of gastric and/or duodenal ulceration.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study.
- •History or presence of smoking.
- •Volunteers consumed tobacco/tobacco containing products, pan or pan masala, gutkha, masala (containing betel nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
- •Volunteers consumed caffeine and/or xanthine- containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study
- •Major illness during the 90 days before screening.
- •Participation in a drug research study within 90 days of screening.
- •Donation of blood within 90 days of screening.
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
- •History or presence of easy bruising or bleeding.
- •Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
- •Pregnant woman and nursing mothers.
- •Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing.
- •Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
- •Difficulty in swallowing solids like capsules, tablets.
结局指标
主要结局
To investigate the time-dependent changes in glutathione concentrations in blood fractions following the oral administration of Glyteine 400 mg capsules.
时间窗: The pre-dose blood samples (04 mL each) will be collected at -12.00,-2.00, and 0.00 hours (basal/homeostasis levels) prior to Glyteine administration. Post-dose blood samples (04 mL each) will be collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours.
次要结局
- To evaluate the safety & tolerability of orally administered Glyteine 400(mg capsules.)
研究者
Dr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
研究点 (1)
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