Healthy volunteers (individuals without a specific disease)
Conditions
Interventions
Intervention 1: Intervention group: In the intervention group, volunteers receive one oral capsule of tamsulosin hydrochloride 0.4 mg of the test product produced by Dana Pharmaceutical Company. The a
Sponsors
Dana Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Kidney function tests including urinalysis and glucose, urea, creatinine, and nitrogen liver function tests including SGOT, SGPT, total protein, and bilirubin, general tests such as red and white blood cell counts, hematocrit, and platelet count.
Exclusion criteria
Exclusion criteria: Smoking, alcohol and drug use, poor liver and kidney function Sensitivity to tamsulosin. People with AIDS, hepatitis B or C, and syphilis. History of serious digestive, hepatic, renal, and cardiovascular problems. Patients with a history of chronic diseases such as blood pressure or blood lipids who have not taken medication in the previous two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome variables of this study include the pharmacokinetic parameters of tamsulosin in plasma, which are measured to assess bioequivalence between the test and reference products, including maximum plasma concentration (Cmax). Timepoint: 0 (before administration), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7.5, 8, 10, 12, 24, 36, and 48 hours after oral administration of the drug. Method of measurement: High-performance liquid chromatography system: Waters Alliance HT Detector: Quattro Premiere XE triple quadrupole mass spectrometer (Waters–Micromass, United Kingdom) with positive electrospray ionization and multiple reaction monitoring Chromatography column: Phenomenex carbon type VIII with dimensions of 150 × 4.6 mm and particle size of 5 µm.;Area under the concentration-time curve from zero to the last measurable time (AUC0–t). Timepoint: 0 (before administration), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7.5, 8, 10, 12, 24, 36, and 48 hours after oral administration of the drug. Method of measurement: High-performance liquid chromatography system: Waters Alliance HT Detector: Quattro Premiere XE triple quadrupole mass spectrometer (Waters–Micromass, United Kingdom) with positive electrospray ionization and multiple reaction monitoring Chromatography column: Phenomenex carbon type VIII with dimensions of 150 × 4.6 mm and particle size of 5 µm.;Area under the concentration-time curve from zero to infinity (AUC0–8). Timepoint: 0 (before administration), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7.5, 8, 10, 12, 24, 36, and 48 hours after oral administration of the drug. Method of measurement: High-performance liquid chromatography system: Waters Alliance HT Detector: Quattro Premiere XE triple quadrupole mass spectrometer (Waters–Micromass, United Kingdom) with positive electrospray ionization and multiple reaction monitoring Chromatography column: Phenomenex carbon type VIII with dimensions of 150 × 4.6 mm and particle size of 5 µm. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactYousef Javadzadeh
Tabriz University of Medical Sciences
Outcome results
None listed