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IRCT20111107008022N8 IRCT 2022-01-28 Exir Pharmaceutical Company Bioequivalency study of two different Pantoprazole formulations Comparative bioequivalence study of two different Pantoprazole 40mg formulations (Exir Pharmaceutical Company & reference) in 24 Iranian volunteers 2022-01-28 anticipated 24 Complete https://irct.ir/trial/61399 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: In this study, 24 volunteers were randomly divided into two groups of 12 test (A) and reference (B) drug recipients by Excel software, then in the second phase, groups A and B will be cross-referenced to the test and drug recipients. Randomization method: First I create a Microsoft Excel worksheet, in column 1 I write the number of candidates (1 to 24). In the second column, we write the groups in which the samples are placed (reference and test). 12 The first sample as a reference and the next 12 samples as a test sample. In column 3, we add the randomization formula (a function called RAND). Filter the contents of column 3 in ascending or descending order to make it random. Finally, the number of candidates is divided into two groups: reference and test, Blinding description: In this project, the volunteers, person responsible for blood sampling and analyzer are kept blind. To blind these people, all the information collected is coded to the researcher, and after the analysis is completed, codes will be opened. Bioequivalence Health volunteers. Intervention group: Oral administration of a single dose of 40 mg pantoprazole tablets made by Takeda company to 12 volunteers in two periods. The interval between two periods, called washout is the time when the drug is removed from the body and its duration is calculated as 5 to 7 half-lives of the drug.. Yes - There is a plan to make this available What will be shared: The pharmacokinetic data obtained from the study are for each volunteer in both the test and reference groups. When: 6 months after the end of the study To whom: All researchers and clinical specialists Conditions: There is no denial of access to data Where to obtain: The results of the project are reported in the form of a published paper. Article will be available after it is published. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir" How to obtain: There will be no problem accessing results when publishing results in online articles. The wait time to access the results will be 3 months after the project is completed. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir". Comments:
public Katayoun Derakhshandeh
Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1590 k.derakhshandeh@umsha.ac.ir Hamedan University of Medical Sciences scientific Katayoun Derakhshandeh
Faculty of Pharmacy , Hamadan University of Medical Sciences, Shaheed Fahmideh Blvd., In front of Mardom Park, Hamadan, Iran
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3838 1590 k.derakhshandeh@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) 24 healthy male and female volunteers will participate in this study Aged 18 to 45 years based on laboratory safety tests Paraclinical health based on tests performed No history of diseases affecting drug pharmacokinetic processes Lack of any chronic or acute medication at least 1 week before the start of the study Adherence to the criteria on the basis of moral obligation and signed an informed consent Actual weight (TBW) in the range of 20% IBW 20 years 40 years Both Subject showed clinically relevant deviations from normal in physical examination. Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day. Use any medication within 14 days before the first treatment. A history of allergic to biguanides Treatment - Drugs Intervention group: Oral administration of a single dose of 40 mg pantoprazole tablets made by Takeda company to 12 volunteers in two periods. The interval between two periods, called washout is the time when the drug is removed from the body and its duration is calculated as 5 to 7 half-lives of the drug. Drug plasma concentration. Timepoint: blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h following drug administration. Method of measurement: Using HPLC instrument. Pharmacokinetic parameters: Half-life, Cmax The peak plasma concentration of a drug after administration, The volume of distribution, and Clearance. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0 and12.0 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models. Exir Pharmaceutical Company Approved 2022-01-21 Ethics committees of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Beside Mardom amusement Park, Shahid Fahmideh Blvd, Hamadan , Iran Hamadan Hamadan Iran (Islamic Republic of)