Bioequivalence study of Aprepitant 125 mg capsule in 24 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic Actover.Aprepitant 125 mg capsule with brand EMEND® Merk capsule..
- Registration Number
- IRCT20180620040164N10
- Lead Sponsor
- ACtover Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 26
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).