Protocol summary
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Study aim
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Bioequivalence study of tofacitinib 5mg manufactured by Zistdaru danesh company (Tofaxha5mg) versus originator brand (Xeljanz 5mg) manufactured by pfizer company
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Design
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Bioequivalence study, crossover, a blind, 24 healthy volunteers, a simple randomization was used for randomization
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Settings and conduct
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The study will be conducted in a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be conducted in two 12-hour periods. The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources at this time should be at least 5 to 7 half-life of the drug. Given that the biological half-life of the drug is in drug form, the time to clear the drug will be one week. Blood samples are taken by the doctor immediately before and after the drug is taken by the volunteers, and the steps for preparing the samples include plasma separation and drug extraction to analyze the amount of drug on them.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: General Health (Liver, Heart and Kidney), Body Mass Index (18-28), Conscious Consciousness, Age (18-60 years old)
Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Pregnancy, Alcoholism and Narcoticism, History of allergy to Tofacitinib
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Intervention groups
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In this study, two groups of intervention and control are not applicable. Both groups will receive test-reference medicine and testing on two different occasions, and therefore the test results will be independent of individual differences and will only indicate differences in the formulation of the two drugs.
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Main outcome variables
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Maximum drug concentration, Time to reach to maximum drug concentration, Half life of drug
General information
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Reason for update
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Changing the sampling center
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200623047902N2
Registration date:
2021-07-07, 1400/04/16
Registration timing:
registered_while_recruiting
Last update:
2024-07-18, 1403/04/28
Update count:
1
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Registration date
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2021-07-07, 1400/04/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-06, 1400/04/15
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Expected recruitment end date
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2021-07-21, 1400/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Bioequivalence study of Tofaxha 5mg and comparison with Xeljanz 5mg formulation in healthy volunteers
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Public title
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Bioequivalence study of Tofaxha 5mg
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
General Health (Liver, Heart and Kidney)
Body Mass Index (18-28)
Conscious Consciousness
Age (18-60)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Pregnancy
Alcoholism and Narcoticism
History of allergy to Tofacitinib
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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Bioequivalence
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Groups that have been masked
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Sample size
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Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
13
blood sample
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first twelve are considered as (first sequence: Tofaxha recipient) and the second twelve are considered as (second sequence: Xeljanz recipient). The volunteers don't have any information about taking test drug or brand drug
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study is a single-blinded clinical trial (volunteers). Tofaxha and Xeljanz are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-20, 1400/03/30
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1400.054
Health conditions studied
1
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Description of health condition studied
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In this study, the disease is not examined. The subject of the study is the bioequivalence study of Tofacitinib 5mg tablet of test and reference in healthy volunteers.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Determination of concentration of drug in bood
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Timepoint
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After taking blood sample
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Method of measurement
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HPLC-MASS MASS
Secondary outcomes
1
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Description
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Time to reach maximum concentration
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Timepoint
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After determining the amount of drug
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Method of measurement
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Observe drug concentrations at different times
2
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Description
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Area under curve
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Timepoint
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After determining the amount of drug
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Method of measurement
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Calculation
Intervention groups
1
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Description
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Intervention Group 1: Volunteers take Tofaxha 5mg tablet, which is manufactured by Zistdaru danesh Company and contains 5 mg of Tofacitinib ,as a test product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the drug in the blood is determined.
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Category
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Treatment - Drugs
2
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Description
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Intervention Group 2: Volunteers take Xeljanz tablet, which is manufactured by pfizer Company and contains 5 mg of tofacitinib, as a reference product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the drug in the blood is determined.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zistdaru Danesh Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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blood concentration data
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When the data will become available and for how long
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8 months after publication of results
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To whom data/document is available
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University researchers
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Under which criteria data/document could be used
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University researchers
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From where data/document is obtainable
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Elham Ghasemian Ghasemian@zistdaru.ir
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What processes are involved for a request to access data/document
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After evaluation of reasons to apply, it will be sent during 60 working days
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Comments
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