Health volunteers.
Conditions
Interventions
Intervention group: Oral administration of a single dose of 40 mg pantoprazole tablets made by Takeda company to 12 volunteers in two periods. The interval between two periods, called washout is the t
Sponsors
Exir Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 24 healthy male and female volunteers will participate in this study Aged 18 to 45 years based on laboratory safety tests Paraclinical health based on tests performed No history of diseases affecting drug pharmacokinetic processes Lack of any chronic or acute medication at least 1 week before the start of the study Adherence to the criteria on the basis of moral obligation and signed an informed consent Actual weight (TBW) in the range of 20% IBW
Exclusion criteria
Exclusion criteria: Subject showed clinically relevant deviations from normal in physical examination. Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day. Use any medication within 14 days before the first treatment. A history of allergic to biguanides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h following drug administration. Method of measurement: Using HPLC instrument. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Half-life, Cmax The peak plasma concentration of a drug after administration, The volume of distribution, and Clearance. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0 and12.0 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKatayoun Derakhshandeh
Hamedan University of Medical Sciences
Outcome results
None listed