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IRCT20130603013572N4 IRCT 2020-08-10 Nano Daru pharmaceutical Co. Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers 2020-08-22 anticipated 48 Complete https://irct.ir/trial/47736 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Simple randomization administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to volunteer's allocated number. Each subject is identified by a number from 1 to 48 according to their entrance to volunteers' list in screening day. Randomly, Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug, Blinding description: Volunteers are blind in this study. The volunteers, according to the predetermined random table that is available to the researcher, are in one of the groups receiving the test or reference drug. Volunteers are aware that they are receiving the test drug (Iranian) and the reference drug (approved drug), but they do not know in which study period they will receive the test and reference drug. Bioequivalence Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers. 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 2: Control group: Single dose administration of Injectable Extended-Release Naltrexone (Vivitrol®) (380 mg) manufactured by Alkermes pharma Co. in 24 healthy volunteers. Yes - There is a plan to make this available What will be shared: Only protocol and methods of study are shareable When: Starting access 6 months after publication of data To whom: Pharmaceutical and medical sciences researchers Conditions: Using is not authorized Where to obtain: contact with E-mail of the main researcher How to obtain: Personal and academic details and the aim of data request. Comments:
public Dr. Mohammadreza Rouini
16 Azar street, Tehran university of medical sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammadreza Rouini
16 Azar street, Tehran university of medical sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) healthy male and female volunteers Age: between 18 and 55 years old BMI: between 18.5 and 30 kg/m2 18 years 55 years Both 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. Other Other Intervention group: Single dose administration of Injectable Extended-Release Naltrexone (Exopio®) (380 mg) manufactured by Nano Daru pharma Co. in 24 healthy volunteers Control group: Single dose administration of Injectable Extended-Release Naltrexone (Vivitrol®) (380 mg) manufactured by Alkermes pharma Co. in 24 healthy volunteers 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. 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. Nano Daru pharmaceutical Co. Approved 2020-05-05 Vice-chancellor in research affairs- Tehran university of medical sciences Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)