Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions

NCT02306902 | Completed

• 1 other identifier: 243_FENOF_09
• Study Type: interventional
• Target: 24
• 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 Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules 130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals Corp. Waltham, MA 02451 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 fenofibric acid

  0-96 hrs

• Peak Plasma Concentration (Cmax) of fenofibric acid

  0-96 hrs

Study Arms (2)

Test

EXPERIMENTAL

Fenofibrate Capsules, USP 130 mg

Drug: fenofibrate

Reference

ACTIVE COMPARATOR

ANTARA® (fenofibrate) Capsules 130 mg

Drug: ANTARA® (fenofibrate)

Interventions

fenofibrate DRUG

130mg, Capsules

Test

ANTARA® (fenofibrate) DRUG

130mg, Capsules

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 his 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 dietary habit.

You may not qualify if:

• Subject had history of hypersensitivity to fenofibrate or any related drug or to any other drug.
• Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
• Subjects with history of unexplained persistent liver function abnormality.
• Subjects with history of preexisting gallbladder disease.
• Subject had history of myalgia, muscle tenderness or weakness or myopathy
• Subject had any evidence of organ dysfunction or any clinically significant deviation from the normal in physical or clinical determinations.
• Clinically abnormal ECG or Chest X-ray, or hematological and biochemical parameters which was/were outside acceptable limits and was judged clinically significant by investigator.
• Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C Viruses of syphilis infection.
• Investigations with urine samples of the subject showed clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4 /HPF), glucose (Positive) or Protein (Positive).
• Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma, any serious, potentially life-threatening illness.
• Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.
• Subject was a regular smoker, who smoked 10 or more cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
• Subject had history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining for the duration of each study period.
• Use of any regular medication (OTC or prescription) or any drug metabolizing enzyme within 30 days prior to Day 1 of this study.
• Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I dosing).

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

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: November 24, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2014-12