Protocol summary
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Study aim
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Bioequivalence Study of Tacrolimus 1mg manufactured by Alborz Zagros company versus originator brand (Prograf) manufactured by Astellas company
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Design
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Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
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Settings and conduct
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The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is 2 weeks. In the first round of the study, the candidates divide into two groups and the first group receives a test capsule and the second group receives a brand capsule. Blood samples are collected immediately before and after drug administration by volunteers. Then, plasma separation and drug extraction are done and samples are ready for analysis.
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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), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcoholism and Narcoticism, History of allergy to Tacrolimus
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Intervention groups
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Intervention group 1: Program 1mg capsule as a reference
Intervention group 2: Taclirus 1mg capsule as a test
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Main outcome variables
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Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug
General information
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Reason for update
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Changing the name of sampling center
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200623047902N10
Registration date:
2021-11-18, 1400/08/27
Registration timing:
prospective
Last update:
2024-07-18, 1403/04/28
Update count:
1
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Registration date
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2021-11-18, 1400/08/27
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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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2021-12-22, 1400/10/01
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Expected recruitment end date
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2022-02-19, 1400/11/30
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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 Tacrolimus 1mg ( Taclirus) manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition
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Public title
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Bioequivalence study of Tacrolimus 1mg
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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)
Informed consent
Age (18-55 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Tacrolimus
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Age
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From 18 years old to 55 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:
19
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 12 no.s are considered as (first sequence: Alborz Zagros's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the 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). Alborz Zagros's Tacrolimus and Originator brand's capsules 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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2021-11-15, 1400/08/24
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Ethics committee reference number
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IR.TBZMED.REC.1400.738
Health conditions studied
1
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Description of health condition studied
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This study is performed on 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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Drug plasma concentration
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Timepoint
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0; 0.33; 0.66; 1; 1.33;01.66; 2; 2.5; 3; 3.5; 4; 5; 6; 8; 10; 12; 24; 48; 72h after drug administration
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Method of measurement
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LC -MASS-MASS
Secondary outcomes
1
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Description
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Pharmacokinetic parameters
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Timepoint
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After intervention
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Method of measurement
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Theoretical and pahrmacokinetic equations
Intervention groups
1
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Description
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Intervention group: single dose, 3 oral capsules 1mg (Prograf) manufactured by Astellas, as a reference product
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Single dose, 3 oral capsules 1mg (Taclirus) manufactured by Alborz Zagros company as test product
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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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Alborz Zagros 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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These data are secure between researchers and related industries.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available