A crossover bioequivalence study in 24 healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: 1: Oral administration of two tablets of citalopram 10 mg manufactured by Pars Darou Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17
Sponsors
Pars Darou Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Laboratory tests +/- 10% of normal interval Without any history of chronic sickness
Exclusion criteria
Exclusion criteria: History of medicine consumption Donation of blood sample more than 300 ml within last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration time profile, Maximum plasma concentration, AUC. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72, hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration and then calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72, hours after drug administration. Method of measurement: Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Talari
Kharazmi Plasma Center
Outcome results
None listed