Status:
COMPLETED
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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...
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. All subjects fasted overnight for at least 10...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Subject had used an enzyme modifying drugs within 30 days prior to admission of this study.
- Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for subjects who dropout / are withdrawn from the previous study prior to period 1 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.
- Subject had problem(s) in complying with the study protocol.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02306889
Start Date
January 1 2010
End Date
April 1 2010
Last Update
December 3 2014
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