CTRI/2025/07/090511尚未招募3 期
A randomized, double-blind, single-dose, three-treatment, three-period, crossover oral bioavailability study comparing Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions.
Sabinsa Europe GmbH1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年7月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the oral bioavailability of Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions
研究概览
简要总结
This is a randomized, double-blind, single-dose, three-treatment, three-period, crossover oral bioavailability study comparing Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions. The primary objective is to assess the oral bioavailability of investigational products. The secondary objective is safety and tolerability of investigational product. A total of 36 subjects will be enrolled in the study. The total duration of the study will be 26 days.
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
- •All study participants must provide a voluntarily written and signed Informed Consent document to participate in the study.
- •Healthy, non-smoking, non-alcoholic, adult, human volunteer (Male and female (non-pregnant, non-lactating) aged 18 to 45 years.
- •Volunteer with a BMI between 18.5 kg/m2 and 29.9 kg/m2 (inclusive of both) and weight 50 kgs for male and 45 kgs for female volunteers.
- •Healthy according to the laboratory results and physical examination, performed at the time of screening.
- •Volunteer must have a normal renal function (Serum Creatinine up to 1.2mg/dL).
- •Volunteers must have a normal 12-lead electrocardiogram (ECG).
- •Volunteers must have normal chest X- Ray (P/A view).
- •A negative urine screen result for drugs of abuse.
- •A negative alcohol breath or urine test result.
- •Volunteers able to communicate effectively.
- •A negative serum beta hCG test result for female volunteers.
- •Male participant agreeing to use appropriate contraceptive measures like double barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam) and should not donate sperm during the study and for 07 days following last dose of the study medication.
- •If the study participant is a female and is of child bearing potential, she must practice an acceptable method of birth control for the duration of the study and for 07 days following last dose of the study medication as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: Or Is postmenopausal for at least 1 year.
- •Or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteer).
排除标准
- •Known hypersensitivity to Curcumin or any of the excipients in the formulation.
- •History or presence of any medical condition or disease according to the opinion of the physician.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Difficulty with donating blood or difficulty in accessibility of veins.
- •Difficulty in swallowing tablets.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •An unusual or abnormal diet within 48.00 hours prior to study check-in, for whatever reason e.g., because of fasting due to religious reasons.
- •Use of St. Johns’ wort 3 weeks prior to study check-in and during the study.
- •Volunteers who had planned for any surgery during the course of the trial.
- •History or current diagnosis of any cancer.
- •History of gall bladder issues.
- •Volunteer with hyperacidity.
- •Volunteer with gastric/duodenal ulcers.
- •Volunteer with prior use of prescription H2 blockers, proton pump inhibitors, or blood sugar lowering agents.
- •Volunteer who are using CYP3A4 and CYP1A2 inhibitors (e.g., statins, antihypertensives, certain chemotherapeutics).
- •Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute.
- •Respiratory rate less than 14 breaths per minute or more than 18 breaths per minute.
- •Major illness in the past 90 days before screening.
- •Use of any prescribed medication or OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study and for 07 days following last dose of the study medication.
- •Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study.
- •Participation in any clinical study within past 90 days.
- •Donation of blood in the past 90 days prior to study check-in of Period-I.
- •In case of Female participants • Pregnant or lactating Women.
结局指标
主要结局
To evaluate the oral bioavailability of Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions
时间窗: The blood samples will be collected at 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours after drug administration in each period to evaluate the bioavailability.
次要结局
- To assess the safety and tolerability of Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions.(Vital signs (body temperature, pulse rate, blood pressure and respiratory rate), assessment of health and well-being shall be recorded.)
研究者
Dr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
研究点 (1)
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