An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Felodipine Extended Release Tablet (Containing Felodipine 10 mg) of OHM Laboratories Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc) With PLENDIL® Extended Release Tablet (Containing Felodipine 10 mg) Manufactured by Merck & Co. Inc. for AstraZeneca in Healthy, Adult, Male, Human Subjects Under Fed Condition

Ranbaxy Laboratories Limited0 sites80 target enrollmentOctober 2008

ConditionsHealthy

InterventionsFelodipine Felodipine (Plendil®)

DrugsFelodipine Felodipine (Plendil®)

Overview

Phase: Not Applicable
Intervention: Felodipine
Conditions: Healthy
Sponsor: Ranbaxy Laboratories Limited
Enrollment: 80
Primary Endpoint: Area under the plasma concentration versus time curve (AUC) of Felodipine
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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 fed condition.

Detailed Description

All the subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) prior to admission in each period. Only subjects with negative results in these tests were preceded for further activities. Following an overnight fast of at least 10 hour, a high-fat highcalorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of felodipine extended release tablets 10 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

December 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Ranbaxy Laboratories Limited

Responsible Party

Sponsor

Eligibility 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.
•Had a non-vegetarian diet habit.

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.