A double blind. balanced, randomized. single-dose, three-treatment, three-sequence, threeperiod,crossover oral bioavailability study of Product A (Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids)), Product B (Next Generation Ultrasol Curcumin 20%(l00 mgtotal curcuminoids)) compared with Product C(Turmeric Extract 95%(1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Relative absorption will be calculated using AUC values for Product A compared with Product C and Product B compared with Product C
研究概览
简要总结
Primary objectives:
-
To compare the bioavailability/relative absorption of total curcuminoids from a single oral dose of curcumin fonnulations -Product A (Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids)) with Product C (Tunneric Extract 95% (1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
-
To compare the bioavailability/relative absorption of total curcuminoids from a single oral dose of curcumin formulations -Product B (Next Generation Ultrasol Curcumin 20% (100 mg total curcuminoids)) with Product C (Turmeric Extr<1ct 95% (1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
Secondary objective:
To monitor the adverse events and to ensure the safety of the subjects.
Investigational Products
Product A: Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids) equally divided m six capsules as 8.34 mg total curcuminoids/ capsule manufactured by OmniActive Health Technologies Ltd., India.
Product B: Next Generation Ultrasol Curcumin 20% (100 mg total curcuminoids) equally divided m SIX capsules as 16.67 mg total curcuminoids/ capsule manufactured by OmniActive Health Technologies Ltd., India
Product C: Turmeric Extract 95% (1800 mg total curcuminoids) equally divided m six capsules as 300 mg total curcuminoids/ capsule. CURCUMIN C3 COMPLEX® was procured from Sabinsa Corporation and study capsules manufactured by OmniActive Health Technologies India
No of Subjects: 24 healthy adult human subjects will be included in the study. Additionally, 02 stand-by subjects will be included in order to dose 24 subjects in period - I.
Study design:
A double blind, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, crossover oral bioavailability study in healthy adult human subjects under fasting condition.
Housing: The subjects will be housed for at least -60.00 (Day -3) hours prior to investigational product administration and up to 24.00 hours (Day 1) post dose in each period.
No of periods: 03.
Study Duration: The study duration will be for approximately 21 days,which shall include from period I check-in to post study safety assessment with a washout period of 07 days.
Washout period: At least 07 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, adult, human subjects within the age range of ≥18 to 55 years.
- •â€¢ Subjects with a BMI between 20.0-27.0 Kg/m2 • Participation is truly voluntary Subjects should avoid food containing curcumin, black pepper at least 48 hrs before dosing.
- •â€¢ Absence of disease markers of HIV 1 & 2, hepatitis B & C virus.
- •Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, physical examination and systemic examination during the screening A normal 12-lead ECG A normal chest X-ray (PA view) done within past 6 months.
- •Subjects have to be weight stable (weight change <3 kg during last 6 months).
- •Compliance with the requirement of the entire protocol Subjects able to communicate effectively Subjects willing to give written informed consent and adhere to all the requirements of this protocol Subject is a non-smoker and non-alcoholic Additional inclusion criteria for female subjects:- Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or Postmenopausal for at least 1 year, or, Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
排除标准
- •Institutionalized subjects.
- •History or evidence of hypersensitive to curcumin or its metabolites.
- •History or presence of any medical condition or disease according to the opinion of the physician.
- •History or evidence of chronic diseases such as diabetes, hypertension, metabolic syndrome, liver disorders, kidney disorders, pulmonary disease or infections,cardiovascular disease, pancreatic disease, infectious diseases, dermatological problems, arthritis and any cancer.
- •History of hypo and hyperthyroidism.
- •Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding,unintentional weight loss, anemia, dysphagia, or abdominal mass.
- •History of milk, gluten allergies or other known food intolerances and or any food allergies.
- •History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
- •Exclusion of subjects taking ace- inhibitors, cholesterol lowering medications.
- •Subjects participating in aerobic exercise more than three times per week.
- •Habit of consuming high caffeine (more than 5 cups of coffee or tea/day)consumption.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •History of addiction to any recreational drug or drug dependence.
- •Systolic blood pressure less than 90 mm Hg or more than 130 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 80 mm Hg. Pulse rate less than 60 beats per minute or more than 100 beats per minute.
- •Donation of blood (i.e. one unit or 350 mL) in the past 90 days before check-in.
- •Receipt of any prescription drugs or over-the-counter drugs (e.g.: cold preparations antacid preparations and natural products used for therapeutic benefits) within 30 days prior to screening.
- •Use of supplements containing curcumin or its metabolites 30 days prior to period I dosing and during the study duration.
- •Major illness during 90 days before check-in.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to check-in of period.
- •An unusual or abnonnal diet within 48.00 hours prior to check-in of each period, for whatever reason e.g. because of fasting due to religious reasons.
- •Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
- •Consumption of food and beverages containing xanthine (chocolates, tea, coffee or cola drinks) for at least 48.00 hours prior to check-in of each period.
- •Consumed grapefruit and grapefruit like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of each period.
- •Positive results for drugs of abuse (benzodiazepi nes, opioids, amphetamines, cannabinoids, cocaines and barbiturates) in urine during the check-in of each period.
- •â€¢ Positive results for urine alcohol analysis during the check-in of each period.
- •â€¢ Difficulty in swallowing solids dosage forms like tablets or capsules.
- •Additional exclusion criteria for female subjects, Volunteer demonstrating a positive pregnancy test.
- •Volunteers who arc pregnant, currently breast-feeding or who are likely to become pregnant during the study.
- •Volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 30 days before dosing.
结局指标
主要结局
Relative absorption will be calculated using AUC values for Product A compared with Product C and Product B compared with Product C
时间窗: Pk samples will be collected at -4.00,0.00,0.50,1.00,2.00,3.00,4.00,5.00,6.00,8.00,10.00,12.00, and 24.00 hours after drug administration
次要结局
- To monitor the adverse events and to ensure the safety of the(subjects.)