CTRI/2014/05/004641招募中不适用
A randomized, balanced, multi-centre, open-label, single dose, two-treatment, two-period, two-sequence, crossover comparative bioavailability study of test Methotrexate (as Methotrexate Sodium) 3 x 5 mg modified-immediate release capsules (from Disphar International B.V., The Netherlands), with reference Imeth® 6 x 2.5 mg (methotrexate 15 mg) immediate release tablets (from Orion Pharma, Finland), in 16 adult patients with rheumatoid arthritis under fasting condition.
Disphar International BV2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年4月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Bioavailability of the both the formulations (T vs R) will be assessed in relation to the
研究概览
简要总结
The present study aims to compare bioavailability of test Methotrexate (as Methotrexate Sodium) 3 x 5 mg modified-immediate release capsules (from Disphar International B.V., The Netherlands), with reference Imeth® 6 x 2.5 mg (methotrexate 15 mg) immediate release tablets (Orion Pharma, Finland) in 16 adult patients with rheumatoid arthritis under fasting condition
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria 1.Adult patients suffering from rheumatoid arthritis; aged between 18 to 50 years (both inclusive) 2.Patients should already be receiving oral methotrexate 15 mg once weekly for rheumatoid arthritis.
- •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 β-HCG pregnancy test at screening or positive urine pregnancy 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 post-study follow-up (i.e. 7 days after the last dosing in Period II).
- •Female patients using hormonal contraceptives either oral or implants.
- •4.Subjects that intend to father a child during treatment and up to 6 months afterwards.
- •5.Female patients with history of dysmenorrhea requiring medication 6.Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study 7.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.
- •8.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.
- •9.Any treatment which could affect the pharmacokinetic of methotrexate (salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, probenecid, penicillins, Chloroquine, omeprazole, etretinate, co-trimoxazole and trimethoprim etc.) administered within 1 month of starting of study/in past 1 month.
- •10.Patients with history of drug hyper sensitivity to methotrexate or related drugs or to any of the excipient of the formulation 11.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).
- •12.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive.
- •13.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit 14.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.
- •15.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) 16.Patients with clinically significant abnormal results during ultrasonographic examinations.
- •17.Patients with a clinically significant past history or current medical condition of: •Pulmonary disorders (COPD and asthma) •Cardiovascular disorders (especially cardiac blocks) •Neurological disorders (especially seizures, migraine) •GIT disorders including history or presence of significant gastric and/or duodenal ulceration •Renal and/or hepatic disorders •Coagulation disorders •Endocrine disorders (especially diabetes mellitus) •History or presence of cancer 18.Patients who have participated in any other clinical investigation or have bled more than 300 ml in the past 3 months.
结局指标
主要结局
Bioavailability of the both the formulations (T vs R) will be assessed in relation to the
时间窗: D15
primary pharmacokinetic parameters for methotrexate:
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ï‚•ï€ Cmax
时间窗: D15
ï‚•ï€ AUC(0-t)
时间窗: D15
次要结局
- To monitor safety parameters for all the investigational products by performing the clinical(and laboratory examinations and recording adverse events during the study.)
研究者
研究点 (2)
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