A randomized, multicentric, open-label, single dose, two-treatment, two-sequence, two-period, crossover, bioequivalence study of test Methotrexate tablets USP 2.5 mg (from Zhejiang Hisun Pharma Co. Ltd., China) with reference RheumatrexÂ® (methotrexate tablets USP) 2.5 mg of Dava Pharmaceuticals, Inc., USA in 42 adult, patients suffering from psoriasis under fasting condition.

Zhejiang Hisun Pharma Co Ltd5 个研究点分布在 1 个国家目标入组 42 人开始时间: 2014年12月16日最近更新: 2015年2月23日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 42
试验地点: 5
主要终点: oCmax,

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The present study aims to establish bioequivalence of Methotrexate tablets USP 2.5 mg (from Zhejiang Hisun Pharma Co. Ltd., China) with reference RheumatrexR (methotrexate tablets USP) 2.5 mg of Dava Pharmaceuticals, Inc., USA. Methotrexate 2.5 mg at 12-hour intervals for three doses weekly is also recommended dose in the treatment of psoriasis. The protocol is designed for product submission to US FDA. The US FDA OGD has recommended single dose bioequivalence study with methotrexate 2.5 mg strength in psoriasis patients.

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: All

入选标准

•1.Adult patients suffering from psoriasis; aged between 18 to 45 years (both inclusive) 2.Patients should already be receiving 2.5 mg 12 hourly of oral methotrexate with weekly dose is in the range of 5-10.0 mg for psoriasis 3.Patients willing to voluntarily provide written informed consent.
•4.Patients willing to undergo pre and post-study physical examinations and laboratory investigations.
•5.Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in house monitoring and the remaining based on history) and during their clinical stay in each study period.
•6.Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and should agree not to take any amount of alcohol during the study period.

排除标准

•1.Patients incapable of understanding the informed consent process.
•2.Pregnant [female patients with a positive pregnancy test at screening or positive serum Î²-HCG test (done at Check-in of each study period)] or lactating females 3.Female patients of childbearing potential who is unwilling or unable to use an appropriate method of contraception, at least 14 days prior to the first dose of study medication until the poststudy follow-up (i.e. 7 days after the last dosing in Period II).
•Female patients using hormonal contraceptives either oral or implants.
•4.Female patients with history of dysmenorrhea requiring medication 5.Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study 6.Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
•7.Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
•8.Any treatment which could affect the pharmacokinetic of methotrexate (salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, the acidic anti-inflammatory agents, probenecid, penicillins, Chloroquine, omeprazole, etretinate, co-trimoxazole and trimethoprim etc.) administered within 1 month of starting of study/in past 1 month.
•9.Patients with history of drug hyper sensitivity to methotrexate or related drugs or to any of the excipient of the formulation 10.Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates).
•11.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive.
•12.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit 13.Patients who, have clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), c-glutamyltranspeptidase, serum bilirubin, serum glucose (fasting) etc.
•14.Patients with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive) 15.Patients with clinically significant abnormal results during ultrasonographic examinations.
•16.Patients with a clinically significant past history or current medical condition of: â€¢ Pulmonary disorders (COPD and asthma) â€¢ Cardiovascular disorders (especially cardiac blocks) â€¢ Neurological disorders (especially seizures, migraine) â€¢ GIT disorders including history or presence of significant gastric and/or duodenal ulceration â€¢ Renal and/or hepatic disorders â€¢ Coagulation disorders â€¢ Endocrine disorders (especially diabetes mellitus) â€¢ History or presence of cancer 17.Patients who have participated in any other clinical investigation or have bled more than 300 ml in the past 3 months.