Protocol summary
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Study aim
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To demonstrate bioequivalence of single dose test formulation of Razan Pharmed Iranian Esomeprazole 10 mg sachet versus Nexium®(AstraZeneca Co.)
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Design
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Single dose, randomized and crossover bioequivalence study of Esomeprazole 10 mg sachet by Razan Pharmed Iranian Co. with Nexium® (AstraZeneca Co.) in 24 healthy male in two groups under fasting condition.
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Settings and conduct
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Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. Place for Blood and plasma sample analysis: Imam Reza Medical Research and Trainning Hospital. 24 healthy male volunteers received each of two test or reference Esomeprazole 10 mg sachet in random sequence according to the randomization schedule. The interval between receiving the medicine (washout period) is 7 days, If the first sequence receives Iranian medicine, they will receive brand medicine. Blood samples will be taken from all participants before receiving the drug and 48 hours after that at determined time points: 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 5, 6، 7, 8، 10, 12 and 24 hours.
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Participants/Inclusion and exclusion criteria
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Healthy male subjects in the age range of 18-60 years and BMI (Body Mass Index) of 18.5-30. Exclusion criteria: Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma, DM, psychosis or glaucoma and regular smoker.
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Intervention groups
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Intervention group (Test): Esomeprazole 10 mg sachet by Razan Pharmed Iranian Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Control group (Reference): Nexium® (AstraZeneca Co.) is the reference product. In each period, 12 of 24 subjects will be given single dose of this product.
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Main outcome variables
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Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).
General information
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Reason for update
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Editing information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200407046981N12
Registration date:
2021-08-23, 1400/06/01
Registration timing:
prospective
Last update:
2021-08-25, 1400/06/03
Update count:
1
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Registration date
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2021-08-23, 1400/06/01
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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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2021-09-21, 1400/06/30
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Expected recruitment end date
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2021-12-21, 1400/09/30
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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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Randomized, single-dose, crossover comparative bioequivalence study of the Esomeprazole 10mg sachet produced by Razan Pharmed Iranian pharmaceutical Co versus Nexium® (AstraZeneca company) in 24 healthy males under fasting conditions
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Public title
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Study of absorption and elimination rate of Esomeprazole 10 mg sachet in comparison with standard sachet of Esomeprazole (Nexium®).
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
The weight limit for each volunteer is between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Esomeprazole or any ingredients.
Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two week before dosing.
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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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No information
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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:
2
Candidates of the sequences must take one of the Iranian or brand drugs, if the first sequence of the volunteers received the domestic drug after the washout period, they must receive the brand drug. In fact,every single volunteers is used as control for himself.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, a table of random numbers from 1 to 24 is created. The table numbers are assigned to individuals in the order in which the candidates enter the list on the day of the experiment, and the candidates in two groups with numbers 1-12 and numbers 13-24 will receive reference and test medicine, respectively.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2021-08-02, 1400/05/11
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Ethics committee reference number
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IR.TBZMED.REC.1400.471
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 the Esomeprazole 10 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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Peak Plasma Concentration (Cmax)
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Timepoint
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At 0 (before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12 and 24 hour after dosing
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Method of measurement
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High-performance liquid chromatography—mass spectrometry (HPLC-MS)
Secondary outcomes
1
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Description
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AUC (Area Under the Concentration-Time Curve)
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Timepoint
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During 2 months after intervention
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Method of measurement
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Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS
Intervention groups
1
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Description
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Intervention group (Test): Esomeprazole 10 mg sachet, produced by Razan Pharmed Iranian Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. In the second period, after washout, this group (test) will be in the reference group and will use brand drug (Nexium10mg).
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Category
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Treatment - Drugs
2
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Description
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Intervention group (Reference): Esomeprazole 10mg sachet (Nexium), produced by AstraZeneca Company is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. In the second period, after washout, this group (Reference) will be in the test group and will use domestic Esomeprazole 10mg sachet.
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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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شرکت داروسازی رازان فارمد ایرانیان
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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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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be 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