Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories, Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Felodipine

Criteria

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