Bioequivalence investigation of the generic Actover.Aprepitant 125 mg capsule with brand EMEND® Merk capsule..
Conditions
Interventions
Intervention 1: Intervention group: (test): Aprepitant 125 mg capsule, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Interv
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 average 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 the patient consent form.
Exclusion criteria
Exclusion criteria: Subject has a history of mentally or legally incapacitated, significant emotional problems at the time of the study, a history of major psychiatric disorders, clinically significant disease history, cardiac or vascular disorder, asthma or another pulmonary disease, major gastrointestinal abnormalities/peptic ulceration, hepatic or hepatobiliary, neurologic, endocrine, hematologic, renal disease, major genitourinary disease. Known hypersensitivity to Aprepitant or its analogs. 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 the 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 a 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