Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions

Inclusion Criteria: Volunteers who met the following criteria were included in the study * Were in the age range of 18-45 years * Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases * Had voluntarily given written informed consent to participate in this study * Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Exclusion Criteria: * History of known hypersensitivity to Felodipine, related drugs and or any other drug * Individuals with systolic blood pressure \<100 mmHg or \>140mmHg diastolic blood pressure \< 60 mmHg or \>90 mmHg, at the time of admission in period I * History of chronic headache, dizziness and syncope * History of peripheral edema * History of grapefruit juice and / or grapefruit supplements intake in past 48 hours * Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations * Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection * Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count * Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids) * Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol * Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive) * Clinically abnormal ECG or Chest X-ray * History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma head-injury or coma * History of any psychiatric illness which might impair the ability to provide written informed consent * Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period * History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period * Use of any enzyme modifying drugs within 30 days prior to Day 1 of the study * Participation in any clinical trial within 12 weeks preceding Day 1 of the study * Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months