Bioequivalence study in healthy volunteers.
Conditions
Sponsors
Poursina Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Volunteers should be healthy and non smoking The weight range of participating candidates should be between 60-100 kg 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 14 sampling time included pre-dose (time 0) and at the following hours post-dose: 0/5, 1, 1/5, 2, 2/5, 3, 4, 5, 6, 7, 8, 10, and 12 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed Ghanbarzadeh
Darou Shimi Teb Sanjesh Company
Outcome results
None listed