Pharmacokinetics, Losartan , Bioequivalent.
Conditions
Interventions
Intervention 1: Intervention group: 50 mg oral tablet of Losaratan (Dana pharmaceutical company), once daily. Intervention 2: Control group: 50 mg oral tablet of Cozaar ( merck), once daily.
Sponsors
Daana pharma.Co
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: in healthy male and female volunteers
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drug or related products. Significant history or presence of gastrointestinal, kidney disease or any otherconditions known to interfere with the absorption, distribution, metabolism orexcretion of common medications. Significant history of asthma, chronic bronchitis or other bronchospasticcondition. Significant history or presence of glaucoma, cardiovascular or hematologicaldisease. Any clinically significant illness during the 4 weeks prior to day of this study. Maintenance therapy with any drug, or history of drug dependency, alcoholabuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 30 dayspreceding day 1 of this study. Use of enzyme- modifying drugs within 30 days prior to day 1 of this study. Use of any systemic medication (including OTC preparations) within 14 daysprior day 1 of this study. HIV and Hepatitis B and anti HCV antibody positive subjects. Smoking History of difficulty in donating blood Donation of blood within 90 days before first dosing. History of vaccination within one month before first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of drug concentration in blood plasma. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after drug administration. Method of measurement: blood samples collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational.;Maximum plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational.;Area under the plasma concentration–time curves. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: linear trapezoidal method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammadreza Rouini
Tehran University of Medical Sciences
Outcome results
None listed