]>
IRCT20180620040164N38 IRCT 2023-01-03 Actover Pharmaceutical Co. Comparative in vivo evaluation of 2 َLinagliptin 5 mg Tablet formulations. Comparative bioequivalence study of َLinagliptin 5 mg Tablet of Actoverco. and Trajenta of Boehringer as reference in 24 healthy male under fasting. 2022-12-30 anticipated 24 Complete https://irct.ir/trial/67335 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 numbers (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 Diabetes mellitus. Intervention 1: Intervention group 1: Linagliptin 5 mg Tablet , produced by Actoverco. 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: Trajenta 5 mg tablet, produced by Boehringer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 21-day wash-out period the intervention 1 will be given to these subjects. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It's undetermind yet.
public علی آقایی
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, 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 Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 mforoutan@gmail.com Tavan Institute Iran (Islamic Republic of) Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) 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. 18 years 45 years Male Known hypersensitivity or idiosyncratic reaction to linagliptin or inactive ingredients. Acute infection within one week preceding first study drug administration. Subject has a history of severe diseases which have direct impact on the study. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who have used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period. Subjects who have a history of alcohol or substance abuse within the last 5 years. Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. Subject intends to be hospitalized within 3 months after first study drug administration. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days. E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Intervention group 1: Linagliptin 5 mg Tablet , produced by Actoverco. 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: Trajenta 5 mg tablet, produced by Boehringer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 21-day wash-out period the intervention 1 will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 13 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after intervention. 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: 13 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Actover Pharmaceutical Co. Approved 2022-10-25 Ethics Committee,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)