Sedative, hypnotic, or anxiolytic related disorders. Sedative, hypnotic, or anxiolytic related disorders
Conditions
Interventions
Intervention 1: Intervention group 1: Alprazolam 0.5 mg tablet, produced by Karen is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wa
Sponsors
Karen Pharma and Food Supplement 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 values between 18.5-30 (inclusive), calculated as Kg/m2. Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination. 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 who have narrow angle glaucoma or are taking strong CYP3A inhibitors. History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Subjects suffering from muscular trauma 21 days before the beginning of the study. Consumption of caffeine-containing products from 24 hour before dosing through 24 hour after administration. Any clinically significant illness during the 4 weeks prior to the first study drug administration. Hypotension (systolic blood pressure =90 millimeter Hg (mmHg) or diastolic blood pressure =60 mmHg) or hypertension (systolic blood pressure =130mmHg or diastolic blood pressure =90 mmHg). Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Recent use of concomitant medication (prescription or over-the-counter) that could increase the risk of bleeding, or influence alprazolam pharmacokinetics. History of alcohol or drug abuse. 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: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours post intervention in each period. 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: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 & 72 hours post intervention in each period. 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