Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions

December 1, 2014 updated by: Ranbaxy Laboratories Limited

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study Comparing Fenofibrate Capsule 130 mg of Ohm Laboratories Inc., USA (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With Antara® Capsule 130 mg (Containing Fenofibrate 130 mg) of Oscient Pharmaceutical Corporation, USA in Healthy, Adult, Male Human Subjects Under Fed Conditions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) in urine prior to admission in each period.

Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of fenofibrate capsules 130 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.

Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low light condition. The pre-dose blood samples in each period were collected in duplicate (2 x 5 mL), within a period of 1.5 hour before dosing. Post-dose samples were generally collected within 2 minutes of the scheduled time.

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 screening). Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 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.

Exclusion Criteria:

  • 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).
  • Subject had donated and/or lost more than 350 mL of blood in the past 3 months, including blood loss in this study.
  • Consumption of alcohol for 48 hours prior to admission.
  • Consumption of grapefruit juice and or grape fruit supplements containing products for 48 hours prior to admission.
  • Subject had problem(s) in complying with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test
Fenofibrate Capsules, USP 130 mg
Drug: fenofibrate
130mg, Capsules
Active Comparator: Reference
ANTARA® (fenofibrate) Capsules 130 mg
Drug: ANTARA® (fenofibrate)
130mg, Capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of fenofibric acid
Time Frame: 0-96 hrs
0-96 hrs
Peak Plasma Concentration (Cmax) of fenofibric acid
Time Frame: 0-96 hrs
0-96 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 243_FENOF_09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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