A cross over bioequivalence study of sunitinib 50 mg capsule of Sobhanoncology compared to Sutent 50 mg capsule manufactured by Pfizer in 24 healthy volunteers under fasting condition
Evaluation of bioequivalence of Sobhan Oncology Company's Sanitinib Capsules in comparison with the sample of Sutent brand made by Pfizer Company
Design
The study is cross-over. 24 healthy volunteers randomly receive one of the two test or reference drugs in each phase of the study, a total of 13 blood samples is received from the individual
Settings and conduct
On the sampling day, after 10 hours fasting, the volunteers will take a single dose of 20 mg test or reference drug with 240 ml of water, and blood saomples are taken at times of 1، 2، 3، 4، 5، 6، 7، 8، 9، 10، 11، 12، 24، 36، 48 and 72 hours after drug administration, then samples are transferred to -70 freezer after plasma separation finally the plasma drug concentration is determined according to liquid chromatography mass spectrometry (LCMSMS) method. After a wash out period of week in the second phase, the candidates who received the test drug in the first phase will receive the reference sample, and the people who had previously received the reference sample will receive the test sample in the second phase.
Participants/Inclusion and exclusion criteria
Completely healthy volunteer in clinical trials, with normal heart rate and blood pressure; people who have not participated in another clinical trial in the last 3 months.
Intervention groups
One capsule of Sunitinib 50 mg of Sobhan Oncology Company along with 240 ml of water is prescribed to 12 volunteers. The second group: 12 volunteers are prescribed one capsule of Pfizer Sutent along with 240 ml of water. 3 weeks later, this study will be repeated and the group that previously received the test drug now receives the Pfizer drug and vice versa.
Main outcome variables
Plasma concentration of test and reference drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220209053979N3
Registration date:2022-08-08, 1401/05/17
Registration timing:registered_while_recruiting
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
Roya Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 0892
Email address
talari_r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2022-08-12, 1401/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A cross over bioequivalence study of sunitinib 50 mg capsule of Sobhanoncology compared to Sutent 50 mg capsule manufactured by Pfizer in 24 healthy volunteers under fasting condition
Public title
A bioequivalence study of Sunitinib 50 mg capsules of Sobhanoncology compared to Sutent 50 mg Capsule manufactured by Pfizer in 24 healthy volunteers under fasting condition
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
No signs of acute or chronic disease during the screening.
Non-smokers
No known history of drugs abuse at least 6 months prior to being included in the test
Volunteer's consent to use two medically effective methods of contraception, at least one of which is a barrier method (from the date of screening to the completion of the study and within 10 weeks after the last dose of drugs)
The subject's voluntary willingness to sign written informed consent.
Exclusion criteria:
Burdened allergic history
Use of any over-the-counter or prescription drugs (including vitamins, minerals, herbal drugs, in particular containing tutsan), use of any dietary supplements less than 14 days before the day of taking the study drug, and throughout the study
Participation in any clinical studies less than 90 days prior to the beginning of the current clinical study.
Any blood/plasma donation and/or bleeding in the amount of 450 ml, as well as if the volunteers were transfused with whole blood or its components less than 60 days before the start of the study.
Subjects with abnormal heart rhythm (HR at rest ≥ 100 bpm or ≤ 50 bpm) and BP (systolic BP ≤100 mmHg or diastolic BP ≤60 mmHg or systolic BP ≥140 mm Hg or diastolic BP ≥ 90 mmHg) on the day of the examination or in the history.
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
17
About 6 cc of blood per sample
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug (test or reference drug) is removed from the original packaging the day before the study and packed in small disposable containers. Therefore, because it is not in the original packaging, the volunteer and the prescriber do not know which drug is being administered to volunteer.
Each volunteeris also assigned a code that, depending on the code, half of them receive the test drug in the first phase and the other half receive the reference drug, and then in the second phase, vice versa, the group that took the test drug in the first phase in the second phase will receive reference drug. And the group that received the reference medicine takes the test medicine.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
16 Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.020
Health conditions studied
1
Description of health condition studied
Bioequivalence study
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma concentration of Sunitinib 50 mg of Sobhan Oncology and Sutent manufactured by Pfizer Company
Intervention group: Oral administration of a 50 mg sunitinib capsule made by Sobhan Oncology Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Pfizer's drug in and give a blood sample at the above times
Category
Treatment - Drugs
2
Description
Intervention group: Oral administration of a 50 mg sunitinib capsule made by Pfizer Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at 0, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 24, 36, 48 and 72 hours after drug administration. In the second phase after a wash out period of 3 weeks this group take Sunitinib of Sobhan Oncology in and give a blood sample at the above times
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi Plasma Center of Islamshahr
Full name of responsible person
Sara Solgi
Street address
No. 13.First Shahamat Alley,Ali Ibn Abitaleb Street, Namaz Square, Islamshahr,
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Fax
+98 21 5637 8236
Email
Info@kpcir.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sobhan Oncology
Full name of responsible person
Payan Pourhashemi
Street address
No.5, Aviz Ave., Alvand street, Arjantin Sq.,
City
Tehran
Province
Tehran
Postal code
4337188657
Phone
+98 21 8879 9924
Email
info@sobhanoncology.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhan Oncology
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
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor of study
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Namaz Sq.,
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor of study
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Namaz Sq.
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
executor of study
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.13, First Shahamat Alley, Ali Ibn Abitaleb Street, Namaz Sq. ,Islamshahr
City
Tehran
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
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
The study is confidential and must be allowed by Sobhan Oncology for publication