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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Protocol summary
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، 6، 8، 10, 12، 24 and 48 hours.
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.
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 and 48 hours.
مطالعات کلینیکال: مرکز تحقیقات کاربردی دارویی دانشگاه علوم پزشکی تبریز، آنالیز نمونه های خونی و پلاسما: بيمارستان امام رضا - بخش اورژانس، آزمايشگاه بالینی بيمارستان امام رضا. 24 داوطلب سالم مرد هریک از دو ساشه اس امپرازول 10میلی گرم (آزمون یا مرجع) را براساس برنامه تصادفی سازی دریافت کردند. فاصله دریافت داروی بعدی (دوره ی پاکسازی) 7 روز است و پس از این دوره، اگر گروه اول داروی ایرانی دریافت کردند در دفعه بعد داروی برند دریافت خواهند نمود. نمونه های خونی تمامی داوطلبان جهت بررسی های فارماکوکینتیکی قبل از دریافت دارو و 48 ساعت بعد از آن در زمان های تعیین شده: زمانهای صفر (قبل از تجويز دارو)، 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 6، 8، 10, 12، 24 و 48 ساعت جمع آوری خواهد شد.
مطالعات کلینیکال: مرکز تحقیقات کاربردی دارویی دانشگاه علوم پزشکی تبریز، آنالیز نمونه های خونی و پلاسما: بيمارستان امام رضا - بخش اورژانس، آزمايشگاه بالینی بيمارستان امام رضا. 24 داوطلب سالم مرد هریک از دو ساشه اس امپرازول 10میلی گرم (آزمون یا مرجع) را براساس برنامه تصادفی سازی دریافت کردند. فاصله دریافت داروی بعدی (دوره ی پاکسازی) 7 روز است و پس از این دوره، اگر گروه اول داروی ایرانی دریافت کردند در دفعه بعد داروی برند دریافت خواهند نمود. نمونه های خونی تمامی داوطلبان جهت بررسی های فارماکوکینتیکی قبل از دریافت دارو و 48 ساعت بعد از آن در زمان های تعیین شده: زمانهای صفز (قبل از تجويز دارو)، 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 5، 6، 7، 8 ، 10 ، 12و 24 جمع آوری خواهد شد.
مطالعات کلینیکال: مرکز تحقیقات کاربردی دارویی دانشگاه علوم پزشکی تبریز، آنالیز نمونه های خونی و پلاسما: بيمارستان امام رضا - بخش اورژانس، آزمايشگاه بالینی بيمارستان امام رضا. 24 داوطلب سالم مرد هریک از دو ساشه اس امپرازول 10میلی گرم (آزمون یا مرجع) را براساس برنامه تصادفی سازی دریافت کردند. فاصله دریافت داروی بعدی (دوره ی پاکسازی) 7 روز است و پس از این دوره، اگر گروه اول داروی ایرانی دریافت کردند در دفعه بعد داروی برند دریافت خواهند نمود. نمونه های خونی تمامی داوطلبان جهت بررسی های فارماکوکینتیکی قبل از دریافت دارو و 48 ساعت بعد از آن در زمان های تعیین شده: زمانهای صفرصفز (قبل از تجويز دارو)، 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 5، 6، 7، 8، 10, 12، 12و 24 و 48 ساعت جمع آوری خواهد شد.
To demonstrate bioequivalence of single dose test formulation of Razan Pharmed Iranian Esomeprazole 10 mg sachet versus Nexium®(AstraZeneca Co.)
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).
General information
Reason for update
Editing information
Acronym
IRCT registration information
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
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Fatima Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 2700
Email address
molavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Study of absorption and elimination rate of Esomeprazole 10 mg sachet in comparison with standard sachet of Esomeprazole (Nexium®).
Purpose
Health service research
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 60 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
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.
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.471
Health conditions studied
1
Description of health condition studied
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.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
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
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS
Intervention groups
1
Description
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).
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center
Full name of responsible person
Dr Hamed Hamishehkar
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Fax
+98 41 3336 7914
Email
hamishehkar.hamed@gmail.com
Web page address
https://darc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
شرکت داروسازی رازان فارمد ایرانیان
Full name of responsible person
Dr. Zinat Gil
Street address
Unit 1, No. 6, Second Alley, Sarafraz St., Beheshti St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8854 0393
Fax
Email
qp@razanpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
شرکت داروسازی رازان فارمد ایرانیان
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Emami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7111
Fax
+98 31 3668 0011
Email
Emami@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatima Molavi
Position
PhD student of Pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 2700
Fax
Email
Molavif@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available