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IRCT20180620040164N41 IRCT 2023-02-25 Karen Pharma and Food Supplement Co. Comparative in vivo evaluation of 2 Loratadine 10 mg Tablet formulations. Comparative bioequivalence study of Loratadine 10 mg Tablet of Karen Pharma and Food Supplement Co. and Claritine® of NBAYER as reference in 24 healthy male under fasting. 2023-04-26 anticipated 24 Complete https://irct.ir/trial/68725 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer's number (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer. Bioequivalence Allergic rhinitis, unspecified. Intervention 1: Intervention group 1: Loratadine 10 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 wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2: Loratadine 10 mg tablet produced by BAYER is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1will be given to these subjects. No - There is not a plan to make this available Justification or reason for not sharing IPD is It's not specified yet.
public Ali aghaei
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Tavan Institute Iran (Islamic Republic of) Healthy subjects (male) between 20 – 45 years of age and 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. Subjects who agree with patient consent form. 20 years 45 years Male Subjects with known allergy to loratadine. Had history of hypertension. Had Concurrently used enzyme modifying drugs especially erythromycin, MAO inhibitors, ketoconazole, and cimetidine. Had recent history of abdominal pain, epistaxis or sleep disturbances. Had history of any psychiatric illness, which may impair the ability to provide, written informed consent. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Consumption of enzyme modifying drugs within 30 days prior to Day 1 of this study. 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. J30.9 Allergic rhinitis, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: Loratadine 10 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 wash-out period the intervention 2 will be given to these subjects. Intervention group 2: Loratadine 10 mg tablet produced by BAYER is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 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). AUC (Area Under the Concentration-Time Curve). Timepoint: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 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). Karen Pharma and Food Supplement Co. Approved 2023-01-24 Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medica Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)