Bioequivalence investigation of the generic Actoverco. Empagliflozin 25 mg tablet with brand Jardiance 25 mg tablet Boehringer..
Conditions
Interventions
Intervention 1: Intervention group: (test): Empagliflozin 25 mg Tablet, produced by Actoverco. and Food Supplement Co. is the test product. In each period, 12 of 24 subjects will be given single oral
Sponsors
Actover 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 according to the accepted normal values 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: Subjects with known allergy to the products tested. Subjects with chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or got any digestive tract surgery within three years. Subject with a history of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities. Those who have undergone surgery during the first four weeks before the trial or are scheduled to perform surgery during the study period. 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. History of alcohol or drug abuse within 2 years before the start of the study. 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 |
|---|---|
| En Peak Plasma Concentration (Cmax). Timepoint: During 2 months 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: During 2 months 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