Bacterial infections. Other bacterial infections of unspecified site
Conditions
Interventions
Intervention 1: Intervention group 1: Ciprofloxacine 500 mg Tablet, produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this p
Sponsors
Dorsa Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. ubjects that have normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Previous history of allergy to a fluoroquinolone or severe allergic reaction to any medication. History of CNS disorders (e.g. convulsive seizures). History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period. Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed