IRCT20221002056075N2 IRCT 2023-05-14 Aani ِDarman Pharmaceutical Company Bioequivalence of Fenofibrate Evaluation of Bioequivalence of ّFenofibrate ۲۰۰ mg in Healthy Volunteers 2023-01-21 anticipated 24 Complete https://irct.ir/trial/66181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: no, Randomization description: Subjects were simple randomized to either of the two treatment arms (test or reference) separated by a washout period of 7 days. The standard 2 × 2 crossover design is used to assess between two groups (test group A and control group B). Each subject is randomly allocated to either an AB sequence or a BA sequence, Blinding description: The dosage forms are in boxes and the volunteers should not see what he or she takes. The coding of samples are only by code of subject and date. Bioequivalence comparison of test and reference fenofibrate. 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). Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Only the volunteers are by a simple randomizing divided to two groups. So we have a sequence effect. Group A, first test and next week reference. Group B, first reference and next week test. Intervention 2: Control group: The reference (Abbot company, from USA, with brand name of Lipantyl) fenofibrate 200 milligram capsules by a crossover design is given only once to the same volunteers. There we have a washout period (one week). Only the volunteers are by a simple randomizing divided to two groups. So we have a sequence effect. Group A, first test and next week reference. Group B, first reference and next week test. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is order of a pharmaceutical company.