Bioequivalence of Fenofibrate
- Conditions
- comparison of test and reference fenofibrate.
- Registration Number
- IRCT20221002056075N2
- Lead Sponsor
- Aani ?Darman Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
18 to 55 years old, Males and/or non-pregnant, non-lactating females
Body mass index (BMI) from 18.5 to 24.9 weight in kg/(height in meter), ability to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent
having a physical examination with no clinically significant finding and laboratory normal tests,
do not take any chronic or acute medication for at least 1 week before the start of the study
no history of diseases affecting the pharmacokinetic processes of the drug
History of allergic responses to related drugs, or any of its formulation ingredients,
have significant diseases (which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system) or clinically significant abnormal findings during screening, history or presence of bronchial asthma
history or evidence of drug dependence or of alcoholism or of moderate alcohol use, smokers who smoke 10 or more cigarettes per day or those who cannot refrain from smoking during the study period,
history of difficulty with donating blood or difficulty in accessibility of veins,
history of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
volunteers who have received a known investigational drug within five elimination half-life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater,
found positive in urine test for drugs of abuse done before check-in of period,
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of plasma profile of test versus reference drug. Timepoint: From administration of drug since 48 hour. Method of measurement: with HPLC.
- Secondary Outcome Measures
Name Time Method