Primary biliary cirrhosis. Primary biliary cirrhosis
Conditions
Interventions
Intervention 1: Intervention group 1: Ursodeoxychlic acid 300 mg Capsule, produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product
Sponsors
Actover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 50 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 no significant diseases or abnormal findings during laboratory evaluations and clinical examination.Subjects with normal vital signs. Candidates must have normal 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: Hypersensitivity to ursodeoxycholic acid. Cardiovascular disease, pulmonary disease, acute or chronic neurohormonal system, digestive disease and vision disorders in ophthalmology examinations. History of mental illness, dehydration due to diarrhea or vomiting lasting 24 hours prior to drug administration. Systolic blood pressure greater than 130 or less than 100 mmHg. Diastolic blood pressure greater than 85 or less than 60 mmHg. Smokers who smoke more than 10 cigarettes per day and have problems with not smoking during any period of the clinical study. People who have used non-prescription or doctor-prescribed drugs 14 days before the start of the first period and will need to take drugs at the same time during the study. Volunteers who are heavy consumers of caffeinated drinks, fruit juices (grapefruit juice) or follow a special diet (vegetarianism) or do heavy physical activity. History of difficulty in donating blood or donating more than 500 ml of blood in less than seven days before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 11, 24, 48 and 72 hours after intervention.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: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 11, 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 ContactBehzad Montaha sangari
Noor Research & Development Institute
Outcome results
None listed