Angina pectoris. Angina pectoris
Conditions
Interventions
Intervention 1: Intervention group1: Ranolazine 1000 mg ER Tablet , produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After
Sponsors
Actover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 50 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 and 27 (inclusive), calculated as kg/m2. General laboratory tests of biochemistry, hematology, TSH, HIV, HBs and HCV are performed. Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination. Subjects with normal vital signs.
Exclusion criteria
Exclusion criteria: Subjects with known allergy to the products tested. volunteers with associated acute or chronic infections; blood pressure in standing position and after at least 5 minutes of rest, systole less than 90 or more than 140 mmHg and diastole less than 50 or more than 90 mmHg); heart rate less than 50 or more than 90 beats per minute; Abnormalities in ECG include: (PR > 210 msec, QRS complex > 120 msec, QTcF > 430 msec); 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 Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24 and 48 hours after intervention.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 Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24 and 48 hours after intervention.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