Nausea. Nausea
Conditions
Interventions
Intervention 1: Intervention group (test): Aprepitant 125 mg capsule, produced by ?Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of t
Sponsors
Dorsa Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 55 years of age 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.
Exclusion criteria
Exclusion criteria: History of known sensitivity to the tested products Associated acute or chronic infections Systolic blood pressure less than 90 or more than 140 mm Hg and diastolic less than 50 or more than 90 mm Hg. Heart rate less than 50 or more than 100 beats per minute Smoking more than 10 cigarettes a day History of alcohol or drug abuse Loss of more than 500 ml of blood in less than 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 Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24 and 48 hours after intervention.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 Timepoint: 15 blood samples will be withdrawn pre-dose and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24 and 48 hours after intervention.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