Ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group1:(Test) Mesalazine1200 mg E.R. tablet, produced by Iran Hormone Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral d
Sponsors
Iran Hormone Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 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. Systolic blood pressure should not be less than 100 mmHg and diastolic blood pressure should not be less than 60 mmHg while sitting. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Have a normal heart rate and vital signs. The consent of the candidates to all the requirements of the clinical study based on the instructions of the clinical study, which has been confirmed by accepting the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with known allergy to Tested Product Hypertension (blood pressure in a standing position and after at least 5 minutes of rest, systole greater than or equal to 140 mmHg and diastole greater than or equal to 90 mmHg). History of kidney, liver, hematology, cardiovascular and digestive problems that affect the bioavailability of the drug. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. 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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 4, 6, 8, 9, 9.5, 10, 10.5, 11, 12, 24 and 48 hours after intervention.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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 4, 6, 8, 9, 9.5, 10, 10.5, 11, 12, 24 and 48 hours after intervention.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 ContactBehzad Montaha sangari
Noor Research & Development Institute
Outcome results
None listed