Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Single dose administration of Injectable Extended-Release Naltrexone (Exopio®) (380 mg) manufactured by Nano Daru pharma Co. in 24 healthy volunteers. Intervention
Sponsors
Nano Daru pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: healthy male and female volunteers Age: between 18 and 55 years old BMI: between 18.5 and 30 kg/m2
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drug or related products. Significant history or presence of gastrointestinal, kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Significant history of asthma, chronic bronchitis or other broncho spastic condition.Significant history or presence of glaucoma, cardiovascular or hematological disease. Any clinically significant illness during the 4 weeks prior to day of this study. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 30 days preceding day 1 of this study. Use of enzyme- modifying drugs within 30 days prior to day 1 of this study. Use of any systemic medication (including OTC preparations) within 14 days prior to day 1 of this study. HIV and Hepatitis B and anti HCV antibody positive subjects. Smoking History of difficulty in donating blood Donation of blood within 90 days before first dosing. History of vaccination within one month before first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of drug concentration in blood plasma. Timepoint: (0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration. Method of measurement: High performance liquid chromatography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak plasma concentration. Timepoint: (0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration. Method of measurement: observational.;Maximum plasma concentration. Timepoint: (0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration. Method of measurement: observational.;Area under the plasma concentration–time curves. Timepoint: (0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration. Method of measurement: linear trapezoidal method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammadreza Rouini
Tehran University of Medical Sciences
Outcome results
None listed