Comparative in vivo evaluation of 2 Ranolazine 1000 mg ER Tablet and Ranexa® 1000 mg ER Tablet formulations.
- Conditions
- Angina pectoris.Angina pectoris
- Registration Number
- IRCT20180620040164N50
- Lead Sponsor
- Zist Arvand Pharme Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 18 – 45 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.
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;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: 19 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24 and 48 hours after intervention.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 Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: 19 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24 and 48 hours after intervention.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).