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Protocol summary
The study is a single-blinded (volunteers), cross-over and fasting, and on two series of healthy volunteers. Blinding is done by changing the original packaging of medicine. 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. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Simin Bespar Tyef Gostar in Tabriz.
The study is a single-blinded (volunteers), cross-over and fasting, and on two series of healthy volunteers. Blinding is done by changing the original packaging of medicine. 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. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin laboratory in Tabriz.
The study is a single-blinded (volunteers), cross-over and fasting, and on two series of healthy volunteers. Blinding is done by changing the original packaging of medicine. 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. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Simin Bespar Tyef GostarRadin laboratory in Tabriz.
اين مطالعه از نوع یک سویه کور (داوطلبین)، متقاطع و ناشتا و روی دو سری از داوطلبين سالم است. کور سازی با تعویض جعبه های نگهداری دارو انجام میشود. مطالعه در دو بازه زماني ۷۲ ساعته انجام خواهد شد. فاصله اين دو بازه دو هفته در نظر گرفته خواهد شد. در دور اول مطالعه داوطلبين در دو گروه تقسيم شده و گروه اول قرص نمونه و گروه دوم قرص برند دريافت مي نمايند. نمونه های خونی بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، گرفته شده و مراحل آماده سازی نمونه ها و استخراج دارو جهت آناليز مقدار دارو بر روی آنها انجام می گردد. این مراحل در شرکت سیمین بسپار طیف گستر در تبریز انجام میگیرد.
اين مطالعه از نوع یک سویه کور (داوطلبین)، متقاطع و ناشتا و روی دو سری از داوطلبين سالم است. کور سازی با تعویض جعبه های نگهداری دارو انجام میشود. مطالعه در دو بازه زماني ۷۲ ساعته انجام خواهد شد. فاصله اين دو بازه دو هفته در نظر گرفته خواهد شد. در دور اول مطالعه داوطلبين در دو گروه تقسيم شده و گروه اول قرص نمونه و گروه دوم قرص برند دريافت مي نمايند. نمونه های خونی بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، گرفته شده و مراحل آماده سازی نمونه ها و استخراج دارو جهت آناليز مقدار دارو بر روی آنها انجام می گردد. این مراحل در آزمایشگاه رادین در تبریز انجام میگیرد.
اين مطالعه از نوع یک سویه کور (داوطلبین)، متقاطع و ناشتا و روی دو سری از داوطلبين سالم است. کور سازی با تعویض جعبه های نگهداری دارو انجام میشود. مطالعه در دو بازه زماني ۷۲ ساعته انجام خواهد شد. فاصله اين دو بازه دو هفته در نظر گرفته خواهد شد. در دور اول مطالعه داوطلبين در دو گروه تقسيم شده و گروه اول قرص نمونه و گروه دوم قرص برند دريافت مي نمايند. نمونه های خونی بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، گرفته شده و مراحل آماده سازی نمونه ها و استخراج دارو جهت آناليز مقدار دارو بر روی آنها انجام می گردد. این مراحل در شرکت سیمین بسپار طیف گسترآزمایشگاه رادین در تبریز انجام میگیرد.
General information
2022-09-23, 1401/07/01
2024-11-21, 1403/09/01
20222024-0911-2321 00:00:00
2023-03-20, 1401/12/29
2026-03-20, 1404/12/29
20232026-03-20 00:00:00
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Changing the sampling date and place.
Changing the sampling date and place.
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تغییز زمان و محل نمونه گیری
تغییز زمان و محل نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Simin Baspar Teyf Gostar Company
Name of recruitment center - Persian: شرکت سیمین بسپار طیف گستر
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.48,Ferdos Street
Street address - Persian: خیابان فردوس، پلاک 48
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167874434
Phone: +98 41 3384 2724
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Radin laboratory
Name of recruitment center - Persian: آزمایشگاه رادین
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.22, first floor, Moalem st., Abureihan St
Street address - Persian: خيابان ابوريحان، کوي معلم، پلاک 22، طبقه اول
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5154995671
Phone: +98 914 313 5843
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Simin Baspar Teyf Gostar CompanyRadin laboratory Name of recruitment center - Persian: شرکت سیمین بسپار طیف گسترآزمایشگاه رادین Full name of responsible person - English: Javad Shokri Full name of responsible person - Persian: جواد شکری Street address - English: No.48,Ferdos StreetNo.22, first floor, Moalem st., Abureihan St Street address - Persian: خیابان فردوسخيابان ابوريحان، کوي معلم، پلاک 4822، طبقه اول City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 51678744345154995671 Phone: +98 41 3384 2724914 313 5843 Fax: Email: Shokri.j@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Rooyan darou company
Name of organization / entity - Persian: شرکت رویان دارو
Full name of responsible person - English: Seyed Ahmadreza Mirmotalebi
Full name of responsible person - Persian: سیداحمد رضا میر مطلبی
Street address - English: No. 13, Maragheh Alley, Ostad Nejatollahi St., Enghelab Ave
Street address - Persian: خیابان انقلاب. خیابان استاد نجات اللهی. کوچه مراغه. پلاک ۱۳
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1599677811
Phone: +98 21 5780 3000
Fax:
Email: info@rooyandarou.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Rooyan darou company
Name of organization / entity - Persian: شرکت رویان دارو
Full name of responsible person - English: Seyed Ahmadreza Mirmotalebi
Full name of responsible person - Persian: سیداحمد رضا میر مطلبی
Street address - English: No. 13, Maragheh Alley, Ostad Nejatollahi St., Enghelab Ave
Street address - Persian: خیابان انقلاب، خیابان استاد نجات اللهی، کوچه مراغه، پلاک ۱۳
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1599677811
Phone: +98 21 5780 3000
Fax:
Email: info@rooyandarou.com
Web page address:
contact.organization_id: Name of organization / entity - English: Rooyan darou company Name of organization / entity - Persian: شرکت رویان دارو Full name of responsible person - English: Seyed Ahmadreza Mirmotalebi Full name of responsible person - Persian: سیداحمد رضا میر مطلبی Street address - English: No. 13, Maragheh Alley, Ostad Nejatollahi St., Enghelab Ave Street address - Persian: خیابان انقلاب.، خیابان استاد نجات اللهی.، کوچه مراغه.، پلاک ۱۳ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1599677811 Phone: +98 21 5780 3000 Fax: Email: info@rooyandarou.com Web page address:
Protocol summary
Study aim
Bioequivalence Study of Everolimus 10mg tablet manufactured by Rooyan Darou (Everolimus-Aqvida) company versus originator brand (Afinitor) manufactured by Novartis company
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded (volunteers), cross-over and fasting, and on two series of healthy volunteers. Blinding is done by changing the original packaging of medicine. 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. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin laboratory in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-65 years old);
Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Everolimus
Intervention groups
Intervention group 1: Afinitor 10mg tablet as a reference
Intervention group 2: Everolimus-Aqvida 10mg as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug
General information
Reason for update
Changing the sampling date and place.
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N20
Registration date:2022-09-05, 1401/06/14
Registration timing:prospective
Last update:2024-07-30, 1403/05/09
Update count:1
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Everolimus-Aqvida 10mg manufactured by Rooyan darou versus Afinitor 10 mg in healthy volunteers in the fasted condition
Public title
Bioequivalence study of Everolimus 10mg tablet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-65 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcohol and drug addiction
History of allergy to Everolimus
Age
From 18 years old to 65 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
30
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
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: Rooyan darou'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
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Rooyan darou's Everolimus and Originator brand 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
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.463
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
Immediately before drug consumption and , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h after drug administration
Method of measurement
Liquid Chromatography Mass-Mass
Secondary outcomes
1
Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
After determining the drug concentration in the sample at different times, the time to reach the maximum drug concentration in plasma is recorded.
2
Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time
Intervention groups
1
Description
Intervention group: single dose, one oral tablet 10mg(Afinitor) manufactured by Novartis, as a reference product
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral Everolimus 10mg tablets manufactured by Rooyan darou company as test product