Ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group1: Mesalazine 500 mg ER Capsule , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-d
Sponsors
Karen Pharma and Food Supplement Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2 Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Subjects with clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations Subjects with known allergy to the products tested or NSAIDs. Significant clinical illness within 3 weeks prior to screening. History of GI surgery or any other surgery within the past 3 months. History of any significant disease that jeopardize safety of the subject or validity of test results. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. History of alcohol or drug abuse. Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity; A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed