An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare rate and extend of orally administered molecule to prove bioequivalence on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects under fasting conditions.
研究概览
简要总结
An Open label, balanced, randomized,two-treatment, two-sequence, two-period, single oral dose, crossover,bioequivalence study on Diclofenac potassium 150 mg XR tablet of Zonaindustrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adulthuman subjects under fasting conditions.
24 Subjects will be enrolled in the study.
Primary objective:
To compare rateand extend of orally administered molecule to prove bioequivalence on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este,Venezuelawith Voltaren150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjectsunder fasting conditions.
Secondary objective:
To monitor the safety of the study subjectsafter administration of Diclofencac 150 mg XR tabletin healthy adult human subjects under fasting conditions.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •2 Willing to be available for the entire study period and to comply with protocol requirements.
- •3 Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •4 Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
- •5 Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
- •6 With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no.
- •7 With a normal or clinically non-significant 12-lead ECG.
- •8 With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
- •9 Non-smokers and willing to abstain from smoking or chewing any tobacco containing product at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points.
排除标准
- •1 Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 2 Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs. 3 History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 4 History of severe infection or major surgery in the past 6 months. 5 History of Minor surgery or fracture within the past 3 months. 6 Significant history or current evidence of malignancy or chronic.
- •infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 7 Any major illness or hospitalized within 90 days prior to the first dosing. 8 Any other clinical condition like diarrhea or vomiting within three days prior to dosing. 9 Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening. 10 Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods. 11 History or presence of significant gastric or duodenal ulceration. 12 Use of any recreational drug or history of drug addiction. 13 History of difficulty in accessibility of veins in arms. 14 Evidence of an uncooperative attitude.
结局指标
主要结局
To compare rate and extend of orally administered molecule to prove bioequivalence on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects under fasting conditions.
时间窗: Day 1 to day 11
次要结局
- To monitor the safety of the study subjects after administration of Diclofencac 150 mg XR tablet in healthy adult human subjects under fasting conditions(Day-1 to day- 11)