Bioequivalence study in healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group1: In this group, volunteers are given a single oral dose of Fenofibrate 200-mg capsules manufactured by Tehran Darou Pharmaceutical Company. In each period, 12 of 24
Sponsors
Tehrandarou Company
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: The weight range of participating candidates should be between 60-100 kg All candidates must be non-smokers Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who have agreed to an informed consent form. All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw
Exclusion criteria
Exclusion criteria: History of allergic or adverse reaction to Fenofibrate or any similar product Volunteers with blood pressure less than 90/60mm Hg or higher than 140/90mm Hg. Individuals who have donated whole blood during the last 2 months Individuals who have donated blood components, such as platelets, within the past 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 16 sampling time included pre-dose (time 0) and at the following hours post-dose: 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, and 72h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehrdad Hamidi
Zanjan University of Medical Sciences
Outcome results
None listed