Protocol summary
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Study aim
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Bioequivalence Study of ٰErlotinib tablet 150 mg manufactured by Zistdaru Danesh company versus originator brand (Tarceva 150) manufactured by Roche company
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Design
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Bioequivalence study, crossover, single blind, 24 healthy volunteers. 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 periods (72h). The interval between these two periods, which is called the wash-out time, is determined 2 weeks. In the first round of the study, the candidates are divided into two groups and the first group receives a test tablet and the second group receives a brand tablet. 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), Informed consent, Age (18-60 years old)
Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcoholism and Narcoticism, History of allergy to ٰErlotinib
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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 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:
IRCT20200623047902N6
Registration date:
2021-08-14, 1400/05/23
Registration timing:
prospective
Last update:
2024-07-20, 1403/04/30
Update count:
1
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Registration date
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2021-08-14, 1400/05/23
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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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2021-09-06, 1400/06/15
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Expected recruitment end date
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2021-11-22, 1400/09/01
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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 erlotinib150mg tablet, manufactured by Zistdaru Danesh co. (Erloxha) Versus Tarceva 150 in healthy volunteers
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Public title
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Bioequivalence study of erlotinib 150 mg
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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 (18-60 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to erlotinib
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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
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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: Erloxha 150) and the second 12 no.s are considered as (second sequence: Tarceva 150 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). Erloxha and Tarceva tablets 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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2021-07-10, 1400/04/19
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1400.069
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 Erlotinib tablet 150 mg 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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Drug plasma concentration
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Timepoint
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Before, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 36,48 and 72h after drug consumption
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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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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, one oral tablet of Tarceva 150 mg (Erlotinib) manufactured by Roche, as 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, one oral tablet of Erloxha 150 mg (Erlotinib) manufactured by Zistdaru Danesh 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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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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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 as secure between researcher 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