Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions

NCT02306889 | Completed

• 1 other identifier: 102_FENOF_10
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA, in healthy, adult, male, human subjects under fasting 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/her 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.

You may not qualify if:

• History of hypersensitivity to fenofibrate or any other related drug.
• Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
• Subjects with history of unexplained persistent liver function abnormality.
• Subject had history of myalgia, muscle tenderness or weakness or myopathy.
• History of abdominal pain in one week preceding the study.
• History of recurrent headache and/or back pain.
• History of constipation and/or nausea in one week preceding the study.
• History and/or any finding of gall bladder disease.
• History of pancreatitis.
• History of drug-induced rash and/or pruritis. - Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Subject had laboratory test parameter(s), which is/are outside acceptable limits and is judged clinically significant.
• Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological 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 more than 10 cigarettes daily or have 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 or has consumed alcohol 48 hours prior to admission.

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: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2014-12