bioequivalence study.
Conditions
Interventions
Intervention group: This study examines the bioequivalence of amiodarone tablets produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control
Sponsors
Behestan Daru Co
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: The weight range of participating candidates must be between 60-100 kg All candidates must be non-smokers The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who agreed to the informed consent form
Exclusion criteria
Exclusion criteria: History of sensitivity or idiosyncrasy to amiodarone or any of the inactive components of the formulation. Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg. Taking any medication within 2 weeks before receiving the medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 15 sampling time till 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed