Comparative in vivo evaluation of 2 Mesalazine 500 mg ER Capsule and PENTASA® 500 mg ER Tablet formulations.
- Conditions
- lcerative colitis.Ulcerative colitis
- Registration Number
- IRCT20180620040164N49
- Lead Sponsor
- Actover Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after intervention.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 Outcome Measures
Name Time Method 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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after intervention.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).