Protocol summary
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Study aim
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Bioequivalence Study of ٰTamsulosin capsule 0.4 mg manufactured by Sanamed company versus originator brand (Omni 0.4 mg) manufactured by Astellas company (Netherlands)
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Design
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Bioequivalence study, crossover, single blind, 18 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 (48h). The interval between these two periods, which is called the wash-out time, is determined one week. In the first round of the study, the candidates are divided into two groups and the first group receives 2 test capsules and the second group receives 2 brand capsules.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 ٰTamsulosin
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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 name of sampling center
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200623047902N4
Registration date:
2021-07-09, 1400/04/18
Registration timing:
prospective
Last update:
2024-07-18, 1403/04/28
Update count:
1
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Registration date
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2021-07-09, 1400/04/18
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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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2021-08-23, 1400/06/01
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Expected recruitment end date
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2021-11-21, 1400/08/30
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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 Tamsulosin 0.4mg manufactured by Sanamed company in healthy volunteers
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Public title
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Bioequivalence study of Tamsulosin 0.4 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 Tamsulosin
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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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Male
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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:
18
More than 1 sample in each individual
Number of samples in each individual:
17
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 18. 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 nine are considered as (first sequence: Tamsulosin 0.4 mg manufactured by Sanamed recipient) and the second nine are considered as (second sequence: Omni 0.4 mg 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). Tamsulosin 0.4 (manufactured by Sanamed) and Omnic 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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2021-07-05, 1400/04/14
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Ethics committee reference number
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IR.TBZMED.REC.1400.309
Health conditions studied
1
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Description of health condition studied
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The 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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Before, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 36 and 48h 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, 2capsules of Omnic 0.4mg, 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, 2capsules of Tamsulosin 0.4mg, Sanamed 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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Sanamed pharma 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