comparison of test and reference fenofibrate.
Conditions
Interventions
Intervention 1: The test (Aani darman company from Iran) fenofibrate 200 milligram capsules by a crossover design is given only once to the same volunteers. There we have a washout period (one week).
Sponsors
Aani ?Darman Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of plasma profile of test versus reference drug. Timepoint: From administration of drug since 48 hour. Method of measurement: with HPLC. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSima Sadrai
Tehran University of Medical Sciences
Outcome results
None listed