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.

aboratorios Leti SAV0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•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 â?? 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. 9.1).
•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.

•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 bloodâ??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.

发起方

aboratorios Leti SAV