NCT02311530

Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Felodipine	Extended Release Tablets, 10mg
DRUG	Felodipine (Plendil®)

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2014-12-08
• Last updated: 2014-12-08