Bioequivalence investigation of the generic Actover.Empagliflozin 12.5 mg + Metformin 1000 mg F.C. tablet with brand Synjardy® Boehringer Ingelheim tablet..
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: (test): Empagliflozin 12.5 mg + Metformin 1000 mg F.C. tablet, produced by Actover is the test product. In each period, 12 of 24 subjects will
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: History of relevant diseases (gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal). History of surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s). Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders. History of relevant orthostatic hypotension, fainting spells, or blackouts. Chronic or relevant acute infections. Hypersensitivity to the investigational drugs and/or to inactive constituents. 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 |
|---|---|
| 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