Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions

NCT02311530 | Completed

• 1 other identifier: 244_FELOD_08
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC) of Felodipine

  0-72 hrs

• Peak Plasma Concentration (Cmax) of Felodipine

  0-72 hrs

Study Arms (2)

Test

EXPERIMENTAL

Felodipine Extended Release Tablets USP 10 mg

Drug: Felodipine

Reference

ACTIVE COMPARATOR

Plendil® Extended release tablets 10 mg

Drug: Felodipine (Plendil®)

Interventions

Felodipine DRUG

Extended Release Tablets, 10mg

Test

Felodipine (Plendil®) DRUG

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Felodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 8, 2014

Record last verified: 2014-12