CTRI/2016/05/006938已完成4 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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.
研究者
相似试验
尚未招募
1 期
An open label, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Ticagrelor tablets 90 mg of Dr. Reddy laboratories limited comparing with that of BRILINTA (film coated tablets) 90 mg in healthy, adult, human subjects under fasting conditionsHealthy subjectsBioequivalence TicagrelorTCTR20210804005Bio-innova and Synchron.Co.,Ltd30
已完成
不适用
A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) in patients with Ovarian CancerCTRI/2014/06/004689Chaya Mazouz24
招募中
不适用
Comparative Bioavailability of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule with Teysuno, (containing Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg) capsule in human subjects with metastatic gastric cancer.CTRI/2021/01/030278BDR Pharmaceuticals Internationals Pvt Ltd
尚未招募
不适用
Bioequivalence study of Gabapentin 300mg capsule of Alborzdarou Pharm Co.,euralgia and neuropathic disorders.IRCT20190706044111N6Alborzdarou Pharm. Co.24
已完成
不适用
Bioequivalence study of Rosuvastatin 20mg of Sobhan Darou Pharm Co.IRCT20190706044111N15Sobhan Darou Pharm. Co.24