Bioequivalence study.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent. Normal findings in the physical examination. Clinical laboratory values within 10% above or below the laboratory’s stated normal range To be a non-smoker
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drug or related products Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the pharmacokinetics of the drug Any clinically significant illness during the 4 weeks prior to day 1 of this study Maintenance therapy with any drug, or history of drug dependence Alcohol abuse, or serious neurological or psychological disease Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study Positive test of HIV and Hepatitis A, B and C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations. Timepoint: 0 , 0.2 , 0.4, 1 2 , 1.5 , , 2.5 , 3 3.5 , , 4 , 4.5 5, 6 , 8 , 12 , 24 48. Method of measurement: High resolution Lc-mass mass. | — |
Countries
Iran (Islamic Republic of)
Contacts
Kermanshah University of Medical Sciences