This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group1: single dose, one oral tablet IMODIUM HCL 2 mg (FC Tablet) manufactured by Janssen , USA as a reference product. after washout period, the volunteers received Loper
Sponsors
Teb Mofid Nikan Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health 18-55 years old Informed consent Body Mass Index Between18-30
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Loperamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: 0,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 h after drug adminstration. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: Immediately after the intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed