Diabetes mellitus. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group 1: Linagliptin 5 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 produ
Sponsors
Dorsa Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Linagliptin or inactive ingredients. Acute infection within one week preceding first study drug administration. Subject has a history of severe diseases which have direct impact on the study. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who have 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. Subjects who have a history of alcohol or substance abuse within the last 5 years. Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. Subject intends to be hospitalized within 3 months after first study drug administration. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 and 72 hours after intervention.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 Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 and 72 hours after intervention.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 ContactBehzad Montaha Sangari
Noor Research & Development Institute
Outcome results
None listed