CTRI/2022/10/046501尚未招募不适用
An Open label, randomized, balanced, two treatment, two sequence, two period, crossover, oral dose comparative pharmacokinetic study of TurmXtra 60N Capsule 250 mg (containing 150 mg of curcuminoids from Water Dispersible Turmeric Extract , 1 x 250 mg) (T) manufactured by Nutriventia Limited. with that of Turmeric extract Capsules (containing 500 mg of C3 Complex curcuminoids and 5 mg bioperine,3 x 500 mg, one capsule 6 hourly) (R) manufactured by Sami-Sabinsa Group Limited, India in normal, healthy, adult, human subjects under fasting conditions.
Nutriventia limited1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年10月27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
- 16
- 试验地点
- 1
- 主要终点
- To test bioavailability between test product and reference product
研究概览
简要总结
The study is conducted to assess relative absorption and relative bioavailability between test product and reference product in 16 healthy, adult, male, human subjects under fasting conditions housed at least 60.00 hrs pre-dose to 24.00 hrs post-dose in a crossover study with 7 days washout period. The Parameters tested in this study are as follows : Primary PK parameters: Cmax, AUC0-t, AUC0-12, AUC0-24 and AUC0-inf. Secondary PK parameters: Tmax, t1/2, Kel and AUCExtrapolated
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male Subjects aged between 18 and 45 years (both inclusive).
- •Subject’s weight within normal range according to normal values for Body Mass Index (18.50 to 29.99 kg/m2) (both inclusive) with minimum of 50 kg weight.
- •Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.
- •Subject having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •Subjects having clinically acceptable chest X-Ray (PA view) whose X-Ray was taken not more than 180 days prior to the dosing of Period
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative urine alcohol test.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •Subjects willing to follow diets free of turmeric and black pepper and any spice mixtures containing turmeric and / or black pepper starting at least 7 days before period I check in till end of period II, including entire study period.
排除标准
- •Hypersensitivity to study drug or related class of drugs or to the inactive ingredients of the test and reference formulation. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological disease or disorder. Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of period
- •History or presence of drug abuse in the past one year. History or presence of significant smoking (more than 10 cigarettes or beedis/day) or could not abstain from smoking during study. History or presence of alcohol abuse in the past one year Alcohol abuse will be defined as >14 drinks per week (1 drink.
- •360 mL beer, 150 mL wine, or 45 mL hard liquor). History or presence of asthma, urticaria or other significant allergic reactions. History or presence of significant gastric and/or duodenal ulceration. Difficulty with donating blood. Difficulty in swallowing solids dosage forms like tablets or capsules. Use of any prescribed medication or OTC medication including vitamins and herbal remedies during last 14 days prior to dosing in period
- •Major illness or hospitalization within past 3 months. Volunteer who have donated 1 unit blood (≥ 300 mL) or participated in a clinical study involving blood sampling within 90 days prior to the first dose of the study drug. Consumption of grapefruit juice within 72 hours prior to dosing and xanthine-containing products, tobacco containing products or any alcoholic products within 48 hours prior to dosing. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. History or presence of significant easy bruising or bleeding. History or presence of significant recent trauma.
结局指标
主要结局
To test bioavailability between test product and reference product
时间窗: PK Samples will be collected at -12.00, -02.00, 00.00, 00.50, 01.00, 02.00, 03.00, 04.00; 05.00, 06.50, 07.00, 08.00, 09.00, 10.00, 11.00, 12.50, 13.00, 14.00, 16.00, 18.00, 20.00 and 24.00 hours following IP administration in each period.
次要结局
- To monitor the safety and tolerability of test product in comparison to reference product(-48.00, -24.00, -2.00, 3.00, 6.00, 11.00, 24.00 hours in each period and Post Study Evaluation)
研究者
研究点 (1)
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