An open label, Randomized, Two treatment, Two-period, Two-sequence, Two-way crossover, pilot comparative bioavailability study of Curcuminoids capsules of Troikaa Pharmaceuticals Ltd., India with Meriva-SR® of Thorne Research, Inc., USA, in healthy adult subjects, under fasting condition.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- •To determine the absorption and assess the comparative bioavailability of single dose of test product Curcuminoids Capsules (a dose equal to 300 mg of Curcuminoids as per COA), Mfd. by Troikaa Pharmaceuticals Ltd., India, with reference drug Meriva-SR® capsules (a dose equal to 295 mg of Curcuminoids as per COA) of Thorne Research, Inc., USA, in healthy adult subjects, under fasting condition.
研究概览
简要总结
Curcumin [1, 7-bis (4-hydroxy-3-methoxyphenyl)-1, 6-heptadiene-3, 5-dionediferuloyl methane] , a major constituent of the yellow spice turmeric derived from the rhizomes of Curcuma spp., is one such polyphenol. Curcumin is the active ingredient in the traditional herbal remedy and dietary spice turmeric. Curcumin has a surprisingly wide range of beneficial properties, including anti-inflammatory, antioxidant, chemopreventive and chemotherapeutic activity.
Curcumin incorporates several functional groups. The aromatic ring systems, which are polyphenols are connected by two α,β-unsaturated carbonyl groups. The two carbonyl groups form a diketone. The diketone form stable enols or are easily deprotonated and form enolates, while the α,β-unsaturated carbonyl is a good Michael acceptor and undergoes nucleophilic addition.
Curcumin exhibits great promise as a therapeutic agent, and is currently in human clinical trials for a variety of conditions, including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer, psoriasis and Alzheimer’s disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •i.Subject who are able and ready to provide written informed consent.
- •ii.Subjects must be healthy male human beings within 18-45 years of age (both inclusive).
- •iii.Subjects should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
- •iv.Subjects must be of normal health as determined by medical history and physical examination, ECG, Chest X-ray (PA View) (valid if the X-ray is taken within one year), and laboratory tests performed within 28 days prior to the commencement of the study.
- •v.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
排除标准
- •i.Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
- •ii.Subjects with significant history of hypersensitivity to Curcuminoids or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- •iii.Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •iv.Subjects with active peptic ulceration or a history of peptic ulceration v.Subject with resting hypotension (BP <90/60) or hypertension (BP > 139 /89).
- •vi.Subject with Pulse rate below 50/ min.
- •and above 99/min.
- •vii.Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •viii.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •ix.Subjects with a history of known food allergy.
- •x.Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
- •xi.Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
- •xiii.Subject who have Smoking History of > 10 Cigarettes / day or Tobacco consumption > 4 packets / day.
- •xiv.Subjects who participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx.
- •90 days) (This 350 mL includes the total blood loss that will occur during the study).
- •xv.Subject with clinically significant abnormal lab values / abnormal ECG or Chest X-ray (PA View).
- •xvi.Subject who has difficulty with donating blood.
- •xvii.Subject with positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission.
结局指标
主要结局
•To determine the absorption and assess the comparative bioavailability of single dose of test product Curcuminoids Capsules (a dose equal to 300 mg of Curcuminoids as per COA), Mfd. by Troikaa Pharmaceuticals Ltd., India, with reference drug Meriva-SR® capsules (a dose equal to 295 mg of Curcuminoids as per COA) of Thorne Research, Inc., USA, in healthy adult subjects, under fasting condition.
时间窗: Pre dose sample of -10.00 hrs also be collected and Pre dose sample (00.00 hour ) will be collected within 30 minutes prior to drug administration and the post dose samples will be collected at 00.50, 0.75, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours respectively.
•To assess the intra subject variability of Curcuminoids Capsules.
时间窗: Pre dose sample of -10.00 hrs also be collected and Pre dose sample (00.00 hour ) will be collected within 30 minutes prior to drug administration and the post dose samples will be collected at 00.50, 0.75, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours respectively.
次要结局
- •To assess the safety of the test and reference products on the basis of adverse events and/ or adverse drug reactions recorded in the study(Vital signs - sitting blood pressure, radial pulse rate, oral temperature will be assessed at admission, prior to dosing (00.00 hrs) and at 02.00, 06.00 and 10.00 hours post-dose and at the time of checkout (24.00 hrs).)